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Every new U.S. recall of food, medicines, medical devices and household products, in one place, updated every day. Search for a product or brand you own.

Counts are for the last 30 days.

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Latest recalls

Medical devices · Oct 21, 2026 · Class II · Ongoing

Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), R…

BioFire Diagnostics, LLC · Salt Lake City, UT, United States

Why: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

Product details, where it was sold and what to do

Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A

Quantity: 3,871

Distribution: Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, H…

Recall number Z-0149-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

FORWARD Gunshot Wound Kit

INTEGRATED MEDCRAFT LLC · East Hampton, CT, United States

Why: Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.

Product details, where it was sold and what to do

FORWARD Gunshot Wound Kit; Model: AFT-GSW;

Quantity: 1033

Distribution: US Nationwide distribution in the states of GA, VA.

Recall number Z-0147-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117

Steris Corporation · Mentor, OH, United States

Why: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

Product details, where it was sold and what to do

RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117

Quantity: 106758 units

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-0156-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J

Medline Industries, LP · Northfield, IL, United States

Why: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Product details, where it was sold and what to do

Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G; 3) AV FISTULA, Medline product number/SKU DYNJ900454C; 4) VEIN PACK SHD, Medline product number/SKU DYNJ68420D; 5) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692J; 6) PRODUCT VASCULAR LAFAYETTE, Medline product number/SKU DYNJ908620D; 7) CHRISTUS SPOHN AV ACCESS PACK, Medline product number/SKU DYNJ60973A; 8) TOL VEIN PACK, Medline product number/SKU DYNJ80861F; 9) THROMBECTOMY PACK-LF, Medline product number/SKU DYNJ0160348B; 10) VEIN PACK, Medline product number/SKU DYNJ67308A; 11) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692I; 12) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692G; 13) BYPASS ACCESSORY, Medline product number/SKU DYNJ52036F; 14) TOL VEIN PACK, Medline product number/SKU DYNJ80861C; 15) MANSFIELD ACCESS GRAFT, Medline product number/SKU DYNJ909985; 16) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732I; 17) CAROTID ENDARTERECTOMY PK, Medline product number/SKU DYNJ85516; 18) RADIAL ARTERY PACK, Medline product number/SKU DYNJ83938; 19) AV FISTULA PACK, Medline product number/SKU DYNJ01966N; 20) FH A V FISTULA PACK-LF, Medline product number/SKU DYNJ51804G; 21) VEIN PACK SHD, Medline product number/SKU DYNJ68420C; 22) VEIN PACK SHD, Medline product number/SKU DYNJ68420B; 23) AV FIS…

Quantity: 8374 kits

Distribution: US Nationwide distribution.

Recall number Z-0171-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H

Ethicon, LLC · San Lorenzo, PR, United States

Why: Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.

Product details, where it was sold and what to do

PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H

Quantity: 1764

Distribution: Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.

Recall number Z-0153-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M

Jenavalve Technology Inc. · Irvine, CA, United States

Why: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

Product details, where it was sold and what to do

JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M

Quantity: 108 units

Distribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.

Recall number Z-0135-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis

W L Gore & Associates, Inc. · Flagstaff, AZ, United States

Why: The potential for the devices to be mislabeled with the incorrect length.

Product details, where it was sold and what to do

Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.

Quantity: 32

Distribution: US Nationwide distribution in the states of GA, RI.

Recall number Z-0158-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated …

Microgenics Corporation · Fremont, CA, United States

Why: Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.

Product details, where it was sold and what to do

MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP

Quantity: 1366

Distribution: Worldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX, CA, LA, SC, OH, MO, OR and the countries of KOR, BGD, THA, ZAF, DEU, VNM, BRA, NZL.

Recall number Z-0159-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115

Steris Corporation · Mentor, OH, United States

Why: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

Product details, where it was sold and what to do

RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115

Quantity: 374 units

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-0154-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L

Jenavalve Technology Inc. · Irvine, CA, United States

Why: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

Product details, where it was sold and what to do

JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L

Quantity: 143 units

Distribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.

Recall number Z-0136-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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Medical devices · Oct 21, 2026 · Class II · Ongoing

IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200…

Beckman Coulter, Inc. · Miami, FL, United States

Why: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table o…

Product details, where it was sold and what to do

IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683

Distribution: Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and the countries of Canada, Mexico, Switzerland, Panama, Ecuador, Japan, Hungary, Italy, Belgium, China, Germany, France, United Kingdom of Great Britain and Northern Ireland, Russian Federation, Singapore, Romania, Argentina, Israel, Spain, Belarus, Guatemala, Colombia, Qatar, Czechia, Reunion, Australia,…

Recall number Z-0161-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM

Medline Industries, LP · Northfield, IL, United States

Why: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Product details, where it was sold and what to do

Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F; 4) AV FISTULA PACK, Medline Product Number/SKU DYNJ67139D; 5) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AD; 6) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333K; 7) EXTREMITY-LF, Medline Product Number/SKU DYNJ905276F; 8) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AC; 9) SPINAL CDS, Medline Product Number/SKU CDS940087AL; 10) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697A; 11) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055; 12) CRANIOTOMY-RICHMOND, Medline Product Number/SKU CDS980929U; 13) ACB EXTRAS PACK-6211, Medline Product Number/SKU DYNJ49516; 14) SPINAL CDS, Medline Product Number/SKU CDS940087AK; 15) SPINAL CDS, Medline Product Number/SKU CDS940087AJ; 16) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AB; 17) SPINAL CDS, Medline Product Number/SKU CDS940087AI; 18) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333J; 19) SPINAL CDS, Medline Product Number/SKU CDS940087AG; 20) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AA.

Quantity: 6069 kits

Distribution: US Nationwide distribution.

Recall number Z-0179-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm

In2bones USA, LLC · Cordova, TN, United States

Why: Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.

Product details, where it was sold and what to do

REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm

Quantity: 29 units

Distribution: US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.

Recall number Z-0157-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

IFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)

SI-BONE, Inc. · Santa Clara, CA, United States

Why: The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.

Product details, where it was sold and what to do

iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)

Quantity: 100 units

Distribution: US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.

Recall number Z-0146-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The…

Cadwell Industries Inc · Kennewick, WA, United States

Why: Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.

Product details, where it was sold and what to do

Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V. Component: Is the cortical component of the IOMAX system

Quantity: 23

Distribution: Worldwide - US Nationwide distribution in the state of TN and the countries of Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland.

Recall number Z-0141-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists

Radiometer Medical ApS · Bronshoj, Denmark

Why: In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.

Product details, where it was sold and what to do

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

Quantity: 5395

Distribution: US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL, TX, GA, NC, PA, SC, MI, OK, WI, AR, MN, OR, UT, WA, SD, IN, TN, AZ, NE, WY, KY, AL, AK, ID, NJ, DE, MT, CT, MS, MO, VT, WV, IA, MD, KS, DC, NV, VA, NM, NH, ND, ME, HI, RI.

Recall number Z-0190-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G

Medline Industries, LP · Northfield, IL, United States

Why: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

Product details, where it was sold and what to do

Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G

Quantity: 3,551 kits

Distribution: US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.

Recall number Z-0185-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K

Medline Industries, LP · Northfield, IL, United States

Why: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Product details, where it was sold and what to do

Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.

Quantity: 235 kits

Distribution: US Nationwide distribution.

Recall number Z-0175-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

TS Femoral Prep Tray, Triathlon

Howmedica Osteonics Corp. · Mahwah, NJ, United States

Why: Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.

Product details, where it was sold and what to do

TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.

Quantity: 582 trays

Distribution: These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.

Recall number Z-0165-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through …

INTELERAD MEDICAL SYSTEMS INCORPORATED · Montreal, Canada

Why: Following a Chromium-based web-browser, report and displayed images may not match.

Product details, where it was sold and what to do

IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through R19; System, Image Processing, Radiological

Quantity: 317 units

Distribution: US Nationwide distribution.

Recall number Z-0186-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class I · Ongoing

HemoslL AcuStar HIT-lgG(PF-4)

Instrumentation Laboratory · Bedford, MA, United States

Why: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

Product details, where it was sold and what to do

HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic

Quantity: 434 units

Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.

Recall number Z-0001-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30…

BioFire Diagnostics, LLC · Salt Lake City, UT, United States

Why: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

Product details, where it was sold and what to do

Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A

Quantity: 1,186

Distribution: Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, H…

Recall number Z-0150-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma…

Medtronic Sofamor Danek USA Inc · Memphis, TN, United States

Why: Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue …

Product details, where it was sold and what to do

Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch" and Orthoblend are produced from a fiber form of DBM Crunch" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are malleable and can be molded or cut into various sizes and shapes according to the intended implant site.

Quantity: 18

Distribution: US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.

Recall number Z-0137-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC

Medline Industries, LP · Northfield, IL, United States

Why: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Product details, where it was sold and what to do

Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AB; 3) CATH LAB ENDO AAA, Medline product number/SKU DYNJ35312I; 4) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AA.

Quantity: 472 kits

Distribution: US Nationwide distribution.

Recall number Z-0174-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R

Medline Industries, LP · Northfield, IL, United States

Why: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Product details, where it was sold and what to do

Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA, Medline product number/SKU DYNJ903705K; 4) PERIPHERAL VASC MAJR-LF, Medline product number/SKU CDS840379O; 5) MINOR VASCULAR PACK-LF, Medline product number/SKU DYNJ0349727D; 6) SJHC VASCULAR PK-LF, Medline product number/SKU DYNJ19906L; 7) CABG PACK-LF, Medline product number/SKU DYNJ0824648K; 8) PERIPHERAL VASC MNR-LF, Medline product number/SKU DYNJ22721N; 9) HEART A PACK, Medline product number/SKU DYNJ0362405S; 10) OPEN HEART, Medline product number/SKU DYNJ907676I; 11) FEM POP MARYVIEW, Medline product number/SKU DYNJ911714; 12) CABG PACK, Medline product number/SKU DYNJ906346G; 13) DEBOER HEART MAIN, Medline product number/SKU DYNJ907914I; 14) OPEN HEART A & B PACK, Medline product number/SKU DYNJ9718008AU; 15) OPEN HEART, Medline product number/SKU DYNJ911483A; 16) CABG ACCESSORY PACK, Medline product number/SKU DYNJ59265; 17) HEART, Medline product number/SKU DYNJ908779B; 18) CARDIOVASCULAR PACK, Medline product number/SKU DYNJ69507F; 19) OFF PUMP CABG CDS, Medline product number/SKU CDS840087AN; 20) PACK CABG CHRG, Medline product number/SKU DYNJ905683D; 21) HEART CDS, Medline product number/SKU CDS840179N;

Quantity: 193374 kits

Distribution: US Nationwide distribution.

Recall number Z-0170-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A

Medline Industries, LP · Northfield, IL, United States

Why: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Product details, where it was sold and what to do

Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.

Quantity: 1900 kits

Distribution: US Nationwide distribution.

Recall number Z-0177-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901…

Medline Industries, LP · Northfield, IL, United States

Why: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

Product details, where it was sold and what to do

Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C DYNJG901002D GENERAL DAVINCI DYNJG901004B DYNJG901004D HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258A KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116D DYKMBNDL116F ROBOTIC GYN DYNJ907827F ROBOTIC PACK DYNJ50474G RR-DAVINCI PROSTATE ACCESSORY DYNJ63392C DYNJ63392F

Quantity: 3,551 kits

Distribution: US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.

Recall number Z-0183-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513

Beckman Coulter, Inc. · Miami, FL, United States

Why: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table o…

Product details, where it was sold and what to do

DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513

Quantity: 2,088

Distribution: Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and the countries of Canada, Mexico, Switzerland, Panama, Ecuador, Japan, Hungary, Italy, Belgium, China, Germany, France, United Kingdom of Great Britain and Northern Ireland, Russian Federation, Singapore, Romania, Argentina, Israel, Spain, Belarus, Guatemala, Colombia, Qatar, Czechia, Reunion, Australia,…

Recall number Z-0160-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class II · Ongoing

Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES,…

Baxter Healthcare Corporation · Deerfield, IL, United States

Why: Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.

Product details, where it was sold and what to do

Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122005NA Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122006 Product Description: LIKORALL 242 ES, WHITE Product Code: 3122006NA Product Description: LIKORALL 242 ES, WHITE Product Code: 3122007 Product Description: LIKORALL 242 ES R2R, NATURAL Product Code: 3122007NA Product Description: LIKORALL 242 ES R2R, NATURAL Product Code: 3122008 Product Description: LIKORALL 242 ES R2R, WHITE Product Code: 3122008NA Product Description: LIKORALL 242 ES R2R, WHITE Product Code: 3122009 Product Description: LIKORALL 242 S, NATURAL Product Code: 3122009NA Product Description: LIKORALL 242 S, NATURAL Product Code: 3122010 Product Description: LIKORALL 242 S, WHITE Product Code: 3122011 Product Description: LIKORALL 242 S R2R, NATURAL Product Code: 3122011NA Product Description: LIKORALL 242 S R2R, NATURAL Product Code: 3122012 Product Description: LIKORALL 242 S R2R, WHITE Product Code: 3122012NA Product Description: LIKORALL 242 S R2R, WHITE Product Code: 3122501 Product Description: LIKORALL 250 ES, NATURAL Product Code: 3122501NA Product Description: LIKORALL 250 ES, NATURAL Product Code: 3122502 Product Description: LIKORALL 250 ES, WHITE Product Code: 3122502NA Product Description: LIKORALL 250 ES, WHITE Pro…

Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. International di…

Recall number Z-0151-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 21, 2026 · Class III · Ongoing

LeadCare II Blood Lead Test Kit

Magellan Diagnostics, Inc. · North Billerica, MA, United States

Why: In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.

Product details, where it was sold and what to do

LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.

Quantity: 321 units

Distribution: US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.

Recall number Z-0162-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

What to do if you own a recalled product

  1. Match it exactly. Recalls usually cover specific lot or batch numbers, "best by" dates, model numbers or sizes. Compare every detail on your product with the notice.
  2. Stop using it. For food and medicine, do not eat, take or give it to pets, even if it looks and smells fine: Listeria and Salmonella do not change how food looks.
  3. Follow the remedy. Most recalls offer a refund, repair or replacement. Return food to the store or follow the company's instructions; for products, contact the company named in the notice.
  4. Do not stop a prescription medicine on your own. Ask your pharmacist or doctor first. They can swap you to an unaffected batch.
  5. Report problems. In the U.S., report illnesses from food or medicine to FDA MedWatch and injuries from products to SaferProducts.gov.

Beware of recall scams

Criminals send fake "recall refund" texts and emails that ask you to pay a "shipping fee" or enter card details. Real recalls never ask for payment. Paste any suspicious recall message into our scam text checker. Read more: Product recalls: how they work and what to do.

Sources: U.S. Food and Drug Administration Enforcement Reports (via openFDA) and the U.S. Consumer Product Safety Commission recall database. FDA enforcement reports list recalls when they are classified, which can be a few weeks after the company's first announcement. Vehicle recalls are available per vehicle in our VIN check.