Browse Device Recalls
3,087 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,087 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 3,087 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 24, 2025 | Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS | There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of... | Class I | Baxter Healthcare Corporation |
| Apr 22, 2025 | ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400... | Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... | Class II | ICU Medical, Inc. |
| Apr 22, 2025 | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACC... | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2025 | ICU Medical Plum Solos, Item number 400011001; infusion pump | Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... | Class II | ICU Medical, Inc. |
| Apr 22, 2025 | Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SK... | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2025 | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A... | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 16, 2025 | VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-02... | It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negati... | Class II | Luminex Corporation |
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 9, 2025 | Centurion Sterile Weitlaner Retractor, Reorder: 67315 | Three is the potential for the retractors to puncture through the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 9, 2025 | Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 | Three is the potential for the retractors to puncture through the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 7, 2025 | Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2... | A cybersecurity vulnerability was discovered through internal testing. | Class I | Baxter Healthcare Corporation |
| Apr 7, 2025 | Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-... | A cybersecurity vulnerability was discovered through internal testing. | Class I | Baxter Healthcare Corporation |
| Mar 24, 2025 | Welch Allyn CP150 Electrocardiograph: | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 7... | A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 24, 2025 | Welch Allyn CONNEX Accessory Power Management Stand: | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | Welch Allyn Connex Vital Signs Monitor (CVSM): | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 8... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff ... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Pr... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 20, 2025 | The Alinity m System is designed to automate the steps for nucleic acid testi... | The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or s... | Class II | Abbott Molecular, Inc. |
| Mar 19, 2025 | Medline procedure kits, labeled as: HAND, REF DYNJ902002J | 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: NON STERILE I&D KIT, REF DYKM1438 | 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) 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 |
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.