Browse Device Recalls
2,910 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,910 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 2,910 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 25, 2025 | Baxter Mobile column TruSystem 7500, Product Code 1717023 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Floor mounting column TS 7500 U, Product Code 1730732 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Floor mounting column TruSystem 7500, Product Code 1717021 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or ... | The air bladders inside the mattress may move out of position when the head of the bed is elevate... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Stationary column TruSystem 7500 U, Product Code 1730731 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Stationary column TruSystem 7500, Product Code 1717020 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500, Product Code 4091000 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Mobile column TruSystem 7500 U, Product Code 1730720 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| 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 | GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 202229... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| 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 19, 2025 | GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001;... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numb... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| 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 |
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.