Browse Device Recalls

1,490 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,490 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,490 FDA device recalls.

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DateProductReasonClassFirm
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Nu... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 24, 2025 Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, ... Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medline medical procedure kits, containing Medtronic Aortic Root Cannula Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 19, 2025 Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCL... There is a potential for the sterility of the device to be compromised. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 19, 2025 Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model ... There is a potential for the sterility of the device to be compromised. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as FACE LIFT. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,1... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY ... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PAC... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; P... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical con... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG;... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 8064172... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, R... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Nu... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ6273... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYN... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJH... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Nu... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number D... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ09230... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ6... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ800... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Numbe... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.