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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 · Sep 30, 2026 · Class II · Ongoing

Achieva XR

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;

Quantity: 15

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3234-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

DeRoyal Industries Inc · Powell, TN, United States

Why: Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

Product details, where it was sold and what to do

REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

Quantity: 7 cases, 140 units

Distribution: US Nationwide distribution in the states of LA,MO, MD, TN, UT.

Recall number Z-3256-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class I · Ongoing

Halyard IV START KIT NON-STERILE

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

Why: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

Product details, where it was sold and what to do

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.

Quantity: 288 kits (6 cases)

Distribution: US Nationwide distribution.

Recall number Z-3194-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large

New York Embroidery Studio, Inc. · Brooklyn, NY, United States

Why: Gowns do not consistently meet the minimum liquid-barrier performance required.

Product details, where it was sold and what to do

New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case.

Quantity: 5,400 gowns

Distribution: US Nationwide distribution in the state of Connecticut.

Recall number Z-3259-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve

Ventec Life Systems, Inc. · Bothell, WA, United States

Why: Labeling; Oxygen Cylinders do not contain required medical gas labeling

Product details, where it was sold and what to do

REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve

Quantity: 25 units

Distribution: US Nationwide distribution in the states of FL, IA, OH, NE, TN.

Recall number Z-3223-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimod…

Heidelberg Engineering GmbH · Heidelberg, Germany

Why: Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.

Product details, where it was sold and what to do

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye

Quantity: 87

Distribution: Worldwide - US Nationwide distribution in the state of Massachusetts and the countries of Australia, Costa Rica, Germany, France, India, Israel, Italy, Canada, Mexico, Netherlands, Austria, Philippines, Poland, Saudi Arabia, Switzerland, Spain. South Africa. Thailand, Czech Republic, United Kingdom, Vietnam.

Recall number Z-3215-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) …

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF, Catalog Number: DYNJ04342M; 6) LAMINECTOMY PACK-LF, Catalog Number: DYNJ43218G; 7) CRANIOTOMY PACK, Catalog Number: DYNJ46024F; 8) LAMINECTOMY PACK-LF, Catalog Number: DYNJ46070C; 9) CRANI PACK, Catalog Number: DYNJ46672B; 10) SPINE TRAY II, Catalog Number: DYNJ52961I; 11) SPINE PACK, Catalog Number: DYNJ53518C; 12) SPINE PACK, Catalog Number: DYNJ54479C; 13) CRANI ADJUNCT PACK, Catalog Number: DYNJ57815; 14) WC SPINE PACK-LF, Catalog Number: DYNJ57971C; 15) PEDI CRANI MAJOR, Catalog Number: DYNJ59338C; 16) LAMINECTOMY PACK-LF, Catalog Number: DYNJ66742C; 17) SPINAL PACK-LF, Catalog Number: DYNJ67543B; 18) LAMINECTOMY PACK, Catalog Number: DYNJ69214A; 19) EPCH LAMINECTOMY I PACK, Catalog Number: DYNJ83098; 20) SPINE, Catalog Number: DYNJ900269I; 21) PACK,CRANIOTOMY, Catalog Number: DYNJ906893C; 22) PACK,CRANIOTOMY, Catalog Number: DYNJ906893D; 23) PACK,CRANIOTOMY, Catalog Number: DYNJ906893F; 24) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192B; 25) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192C; 26) DR MOSHEL CRANI, Catalog Number: DYNJ907920C; 27) SPINE-LF, Catalog Number: DYNJ910956; 28) TOURO OR LAMINECTOMY PACK, Catalog Number: DYNJ912687

Quantity: 4013 kits

Distribution: US Nationwide.

Recall number Z-3269-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm

Olympus Corporation of the Americas · Center Valley, PA, United States

Why: Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

Product details, where it was sold and what to do

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

Quantity: 305 units

Distribution: International distribution in the country of Japan.

Recall number Z-3216-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);

Quantity: 2038

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3236-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector

Olympus Corporation of the Americas · Center Valley, PA, United States

Why: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Product details, where it was sold and what to do

Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.

Quantity: 404 units

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.

Recall number Z-3244-2026 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 30, 2026 · Class II · Ongoing

Cardioroot Woven Collagen Coated Vascular Graft

INTERVASCULAR, SAS · La Ciotat Cedex, France

Why: Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).

Product details, where it was sold and what to do

Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;

Quantity: 16329 (3880 US, 12449 OUS)

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jordan, Kenya, Kosovo, Kuwait, Latvia, Luxembourg, Malaysia, Mauritius, Monaco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom, Yemen.

Recall number Z-3258-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

MR 5300 Model Number (REF): 1. 782110, 2. 782152;

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

MR 5300 Model Number (REF): 1. 782110, 2. 782152;

Quantity: 611

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3241-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade)

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);

Quantity: 37

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3242-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Biomerieux Inc · Hazelwood, MO, United States

Why: The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.

Product details, where it was sold and what to do

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Quantity: 97680 units

Distribution: International distribution to the countries of Austria, Germany, Luxembourg.

Recall number Z-3231-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), …

Midmark Corporation · Versailles, OH, United States

Why: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Product details, where it was sold and what to do

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622

Quantity: 1 units

Distribution: US Nationwide distribution.

Recall number Z-3217-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

NGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100…

Criticare Technologies, Inc. · Warwick, RI, United States

Why: Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.

Product details, where it was sold and what to do

nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R

Quantity: 1,007

Distribution: US Nationwide distribution including in the states and territory of AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and Puerto Rico.

Recall number Z-3253-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Ingenia Elition S and Ingenia Elition X

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);

Quantity: 596

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3239-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors

Fresenius Medical Care Renal Therapies Group, LLC · Waltham, MA, United States

Why: Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Product details, where it was sold and what to do

CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;

Quantity: 1743026 units

Distribution: Domestic: Nationwide Distribution;

Recall number Z-3225-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), …

Midmark Corporation · Versailles, OH, United States

Why: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Product details, where it was sold and what to do

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0350 with Kit Number: 4-000-0722

Quantity: 20 units

Distribution: US Nationwide distribution.

Recall number Z-3219-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class I · Ongoing

INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set

CooperSurgical, Inc. · Trumbull, CT, United States

Why: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

Product details, where it was sold and what to do

INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.

Quantity: 149 boxes (745 units)

Distribution: Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.

Recall number Z-3140-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes

Abiomed, Inc. · Danvers, MA, United States

Why: Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in …

Product details, where it was sold and what to do

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 7. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

Quantity: 3,322 units

Distribution: Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.

Recall number Z-3251-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Achieva 3.0T

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;

Quantity: 210

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3233-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), …

Midmark Corporation · Versailles, OH, United States

Why: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Product details, where it was sold and what to do

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624

Quantity: 153 units

Distribution: US Nationwide distribution.

Recall number Z-3218-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Medline convenience kits containing Healthmark Instrument Channel Brushes

Medline Industries, LP · Northfield, IL, United States

Why: Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.

Product details, where it was sold and what to do

Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.

Quantity: 90 kits (US)

Distribution: US Nationwide distribution in the states of MN and SD.

Recall number Z-3229-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector

Olympus Corporation of the Americas · Center Valley, PA, United States

Why: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Product details, where it was sold and what to do

Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.

Quantity: 816 units

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.

Recall number Z-3247-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Sep 30, 2026 · Class II · Ongoing

MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co

SHANTOU Qiwei industrial Co., Ltd · Shantou, China

Why: cGMP Deviations

Product details, where it was sold and what to do

MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China

Quantity: 2970 units

Distribution: CA only

Recall number D-0854-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Sep 30, 2026 · Class II · Ongoing

Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, …

Sterling Pharmaceutical Services LLC · Dupo, IL, United States

Why: Lack of Assurance of Sterility

Product details, where it was sold and what to do

Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.

Quantity: 47616 bottles

Distribution: USA Nationwide

Recall number D-0859-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Sep 30, 2026 · Class II · Ongoing

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per d…

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Tarrytown, NY, United States

Why: Lack of Assurance of Sterility

Product details, where it was sold and what to do

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15

Quantity: 2,356,248 bottles

Distribution: Nationwide in the USA.

Recall number D-0870-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Sep 30, 2026 · Class II · Ongoing

Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Wal…

Sterling Pharmaceutical Services LLC · Dupo, IL, United States

Why: Lack of Assurance of Sterility

Product details, where it was sold and what to do

Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15.

Quantity: 301114 bottles

Distribution: USA Nationwide

Recall number D-0857-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Sep 30, 2026 · Class II · Ongoing

Major LubriFresh P.M

Sterling Pharmaceutical Services LLC · Dupo, IL, United States

Why: Lack of Assurance of Sterility

Product details, where it was sold and what to do

Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38

Quantity: 34368 tubes

Distribution: USA Nationwide

Recall number D-0861-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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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.