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 19, 2025 | Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; ... | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline Sterile Water, USP, 100mL, REF RDI30295 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; ... | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 5, 2025 | MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Sal... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & ... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS ... | 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) PRECIP TRAY, 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 | Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Mo... | 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) PAIN 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 |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Mod... | 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) ANGIOGRAPHY DRAPE P... | 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) RHINOPLASTY PACK, M... | 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) UTHET TYLER OB PACK... | 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) PERI GYN 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 | 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) LARGE BIOPSY PACK N... | 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) HERNIA REPAIR TOTE,... | 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) UNIVERSAL DRAPE PAC... | 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) IV PACK SOUTH, 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 | Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe... | Class II | Baxter Healthcare Corporation |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAP... | 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) T A PACK, Model N... | 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) OCULOPLASTIC PICK P... | 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) LINE INSERTION PACK... | 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) ANGIO CONSOLIDATED ... | 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) ARTHROSCOPIE DU GEN... | 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) CUSTOM BLOCK KEMP P... | 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) SKIN LESION SET, Mo... | 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) NEURO PACK WRO-LF, ... | 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) STANDARD D&C, 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 | Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, M... | 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) DENTAL PACK-LF, Mod... | 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) LABOR AND DELIVERY ... | 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) RHINOPLASTY PACK, M... | 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) 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 |
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.