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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.

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Latest recalls

Medical devices · Sep 23, 2026 · Class I · Ongoing

Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A; 5) DYNDB3061, Catalog Number: DYNDB3061; 6) DYNDH1245, Catalog Number: DYNDH1245; 7) DYNDH1362, Catalog Number: DYNDH1362

Quantity: 10407 kits

Distribution: US Nationwide distribution.

Recall number Z-3124-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GL…

Howmedica Osteonics Corp. · Mahwah, NJ, United States

Why: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Product details, where it was sold and what to do

DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER - GLENOID #7 5361-6107 SHOULDER - GLENOID #9 5361-6109 SHOULDER - KEELED GLENOID #11 5361-6211 SHOULDER - KEELED GLENOID #5 5361-6205 SHOULDER - KEELED GLENOID #7 5361-6207 SHOULDER - KEELED GLENOID #9 5361-6209 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3200-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5…

Howmedica Osteonics Corp. · Mahwah, NJ, United States

Why: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Product details, where it was sold and what to do

ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO TS TIB INS 72-4-9114 SCORPIO TS TIBIAL INSERT 72-4-0324 SCORPIOFLEX TOTAL KNEE CR 72-16-0512 72-16-0518 72-16-0912 72-16-1112 SERIES II TIBIAL BEAR INSERT NO 11 15MM 3052-1115 UHR BIPOLAR 26X52mm UH1-52-26 UHR BIPOLAR 26X58mm UH1-58-26 UHR BIPOLAR 28X48mm UH1-48-28 UHR BIPOLAR 28X52mm UH1-52-28 UHR BIPOLAR 28X55mm UH1-55-28 UHR BIPOLAR 32X49MM UH1-49-32 UHR BIPOLAR 32X51MM UH1-51-32 UHR BIPOLAR 32X52MM UH1-52-32 UHR BIPOLAR 32X54MM UH1-54-32 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3197-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

REF:B12LT Ethicon Endo-Surgery, Inc

Stryker Sustainability Solutions · Tempe, AZ, United States

Why: Reusable access port system may crack or seperate during use.

Product details, where it was sold and what to do

REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM

Quantity: 2682 units

Distribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, 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, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel …

Recall number Z-3185-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Happiest Baby, Inc

Happiest Baby, Inc · Los Angeles, CA, United States

Why: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

Product details, where it was sold and what to do

Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534 S2101-535 S2101-536 S2101-541 S2101-551 S2102-508-10 S2102-508-9 S2103-501 S2103-502 S2103-504 S2103-508-11 S2103-508-12 S2103-508-13 S2103-508-14 S2103-508-6 S2103-508-7 S2103-508-8

Quantity: 14837

Distribution: US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, 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, Vermont, Virginia, Washington, West Virginia, Wisconsin…

Recall number Z-3176-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A

Medline Industries, LP · Northfield, IL, United States

Why: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

Product details, where it was sold and what to do

Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A

Quantity: 341

Distribution: US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.

Recall number Z-3207-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Brand Name: VERIQA

PTW FREIBURG · Freiburg Im Breisgau, N/A, Germany

Why: When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.

Product details, where it was sold and what to do

Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;

Quantity: 2

Distribution: Worldwide - US Nationwide distribution in the states of GA, NY and the countries of Austria, Belgium, Switzerland, Czechia, Germany, Spain, France, Netherlands, Norway, Poland, Portugal, Romania, T¿rkiye, Chile, United Arab Emirates, Saudi Arabia, Mexico, Hong Kong, Brazil, Tajikistan, Ecuador, Iran, Thailand, Serbia, South Africa, Kazakhstan, Algeria.

Recall number Z-3174-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

NOxBOXi Nitric Oxide Delivery System

NOXBOX LTD · Sittingbourne, N/A, United Kingdom

Why: Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

Product details, where it was sold and what to do

NOxBOXi Nitric Oxide Delivery System.

Quantity: 1,547 units

Distribution: US Nationwide distribution in the state of Georgia.

Recall number Z-3165-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

IV Sets with drip chambers

ICU Medical, Inc. · San Clemente, CA, United States

Why: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Product details, where it was sold and what to do

IV Sets with drip chambers

Quantity: 86,113

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

Recall number Z-3162-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A

Medline Industries, LP · Northfield, IL, United States

Why: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

Product details, where it was sold and what to do

Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A

Quantity: 60

Distribution: US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.

Recall number Z-3209-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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Medical devices · Sep 23, 2026 · Class I · Ongoing

Haylard BASIC BIOPSY TRAY

AVID Medical, Inc. · Toano, VA, United States

Why: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Product details, where it was sold and what to do

Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;

Quantity: 240 kits

Distribution: Domestic: IL, NC, VA, WY;

Recall number Z-3153-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS)

Maquet Cardiopulmonary Gmbh · Rastatt, N/A, Germany

Why: The packaging may not consistently maintain sterile barrier integrity.

Product details, where it was sold and what to do

Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

Quantity: 185617 units (5926 US, 179691 OUS)

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;

Recall number Z-3145-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Pro…

Abiomed, Inc. · Danvers, MA, United States

Why: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Product details, where it was sold and what to do

Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;

Quantity: 4100 units (2785 US, 1315 OUS) 11 10

Distribution: Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

Recall number Z-3150-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, …

Boston Scientific Corporation · Marlborough, MA, United States

Why: A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.

Product details, where it was sold and what to do

Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0

Quantity: 982 units

Distribution: Worldwide - US Nationwide distribution including in the states of AZ, FL, CA, OR, IL, NC, NE, UT, CO, OH, AR, NM, AL, WI, TN, IN, GA, OH, WI, KY, CT, KS, SC, IL, NE, MO, MS, DE, TX, NY, WV, MA, MT, WA, WY, NV, HI, ID, MO, ME, WV, NE, OK, MN, LA, WV, NV, PA, NH, NJ, MI, MO, AK, VA, MS, WY, ME and the countries of Australia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkiye, Canada, Hong Kong, Singapore, Taiwan, Argentina, Chile, Japan.

Recall number Z-3188-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number: DYNDH1695; 7) DYNDH1708A, Catalog Number: DYNDH1708A; 8) DYNDH1714A, Catalog Number: DYNDH1714A; 9) DYNDH1723, Catalog Number: DYNDH1723; 10) DYNDH1740B, Catalog Number: DYNDH1740B; 11) DYNDH1741B, Catalog Number: DYNDH1741B; 12) DYNDH1771A, Catalog Number: DYNDH1771A; 13) DYNDH1908, Catalog Number: DYNDH1908; 14) DYNDH1940, Catalog Number: DYNDH1940; 15) DYNDH1988, Catalog Number: DYNDH1988; 16) DYNDH2002, Catalog Number: DYNDH2002; 17) DYNDH2017, Catalog Number: DYNDH2017. Blood and urine collection kits

Quantity: 47848 kits

Distribution: US Nationwide distribution.

Recall number Z-3127-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080

Quantity: 489 kits

Distribution: US Nationwide distribution.

Recall number Z-3122-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions

GE Healthcare · Chicago, IL, United States

Why: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Product details, where it was sold and what to do

Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions

Quantity: 1856 systems

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3166-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

IV Non-Dedicated Gravity Administration Sets with drip chambers

ICU Medical, Inc. · San Clemente, CA, United States

Why: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

Product details, where it was sold and what to do

IV Non-Dedicated Gravity Administration Sets with drip chambers

Quantity: 2,450

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

Recall number Z-3157-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Howmedica Osteonics Corp. · Mahwah, NJ, United States

Why: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Product details, where it was sold and what to do

TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3204-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

OMNIFIT SERIES I ACET

Howmedica Osteonics Corp. · Mahwah, NJ, United States

Why: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Product details, where it was sold and what to do

OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3196-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A

Quantity: 1100 kits

Distribution: US Nationwide distribution.

Recall number Z-3126-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

Impella Optical Controller with the below product descriptions and corresponding Product Codes

Abiomed, Inc. · Danvers, MA, United States

Why: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Product details, where it was sold and what to do

Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.

Quantity: 1422 units (487 US, 935 OUS)

Distribution: Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

Recall number Z-3149-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS)

Maquet Cardiopulmonary Gmbh · Rastatt, N/A, Germany

Why: The packaging may not consistently maintain sterile barrier integrity.

Product details, where it was sold and what to do

Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

Quantity: 68371 units (1765 US, 66606 OUS)

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;

Recall number Z-3144-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEM…

Wilson-Cook Medical Inc. · Winston Salem, NC, United States

Why: Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

Product details, where it was sold and what to do

Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No

Quantity: 121,241 units (U.S.-49240, O.U.S.-72001)

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Brazil, Canada, Canary Island, Chile, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guatemala, Guadeloupe, Guernsey, Hong Kong, Hu…

Recall number Z-3177-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System

Bayer Medical Care, Inc. · Indianola, PA, United States

Why: Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Product details, where it was sold and what to do

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

Quantity: 27800 kits (556 boxes)

Distribution: US Nationwide distribution.

Recall number Z-3147-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Pi-Cardia Inc

PI CARDIA LTD · Rehovot, N/A, Israel

Why: Transfemoral catheter, positing arm may detached due to weld issue.

Product details, where it was sold and what to do

Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

Quantity: 46 units

Distribution: US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.

Recall number Z-3213-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distrib…

GE Healthcare · Chicago, IL, United States

Why: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Product details, where it was sold and what to do

Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions

Quantity: 1443 systems

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3168-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

REF:B5LT Ethicon Endo-Surgery, Inc

Stryker Sustainability Solutions · Tempe, AZ, United States

Why: Reusable access port system may crack or seperate during use.

Product details, where it was sold and what to do

REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM

Quantity: 205,704 units

Distribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, 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, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel …

Recall number Z-3186-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT…

Howmedica Osteonics Corp. · Mahwah, NJ, United States

Why: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Product details, where it was sold and what to do

ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS 22MM 52MM 2099-2252 CONSTRAINED ACETABULAR INSERTS 22MM 56MM 2099-2256 CONSTRAINED ACETABULAR INSERTS 28MM 61MM 2099-2861 EIUS UNI TIB SMALL RM/LL 9MM 6636-0-419 PCA CONST LINER 32MM NEUTRAL C - SHELL 6299-N-332 SYS 12 CONST LINER 32ID 10 DEG P6 +4MM 6302-H-632 TRIDENT 0 DEG CONSTRAINED INSERT 22D 690-00-22D TRIDENT 0 DEG CONSTRAINED INSERT 22E 690-00-22E TRIDENT 0 DEG CONSTRAINED INSERT 28F 690-00-28F TRIDENT 0 DEG CONSTRAINED INSERT 28G 690-00-28G TRIDENT 0 DEG CONSTRAINED INSERT 32I 690-00-32I TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D TRIDENT CONSTR ACET INSERT 690-10-28K TRIDENT CONSTRAINED INSERT 690-10-22E 690-10-22F 690-10-28G 690-10-28H 690-10-28I Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3201-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR IN…

Howmedica Osteonics Corp. · Mahwah, NJ, United States

Why: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Product details, where it was sold and what to do

ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW C-M110-1-201 BUSHING AND BEARING USE C-MM100253-00 C-MM100253-02 DURACON TIB INSERT LG 12MM MED 14MM LAT C-M066-3-000 EXETER WINGLESS CENTRALISER FOR C-M082-7-302 C-M082-7-303 EXETER WINGLESS CENTRALIZER XSM C-M107-5-301 GMRS EXTRA SM ALL-POLY TIBIA SIZE 11mm C-MM100616-02 GMRS EXTRA SM ALL-POLY TIBIA SIZE 16mm C-MM100616-03 GMRS EXTRA SM ALL-POLY TIBIA SIZE 8mm C-MM100616-01 GMRS SML POLY TIBIA 11MM CASE 100520 C-MM100520-03 GMRS SML POLY TIBIA 16MM CASE 100520 C-MM100520-04 GMRS SML POLY TIBIA 8MM CASE 100520 C-MM100520-02 GMRS SML TIBIA 11MM WITH CASE 100411 C-MM100411-03 GMRS SML TIBIA 14MM WITH CASE 100411 C-MM100411-04 GMRS SML TIBIA 8MM WITH CASE 100411 C-MM100411-02 GMRS TIB INSRT SML 10MM WITH CASE 100507 C-MM100507-04 GMRS TIB INSRT SML 16MM WITH CASE 100507 C-MM100507-06 KALI TIBIAL INSERT LARGE RIGHT 8mm C-M071-6-601 KRH REV TIB INS 16mm THK .655 DIA STEM C-M113-5-603 MRH KNEE TIBIAL INSERT FOR THIN POST C-M067-3-103 MRS RADIAL BUSHING FORITH C-M107-7-800 C-M107-7-801 SELF-PRESSURIZING GLENOID SIZE 9 …

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3199-2026 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.