Browse Device Recalls
1,001 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,001 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 1,001 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 6, 2025 | Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, M... | Devices may have higher than expected amounts of bacterial endotoxin. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, M... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 3, 2025 | Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenien... | Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 31, 2024 | Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item N... | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 31, 2024 | Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600... | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... | Class I | 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.