Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 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 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 3, 2025 | Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Ass... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | FlexLab (FLX) System. Potassium Test System. in vitro diagnostic | The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis,... | Class II | Inpeco S.A. |
| Sep 3, 2025 | FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic | The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysi... | Class II | Inpeco S.A. |
| Sep 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Potential issue that can cause the device to register "phantom" touches in the lower-left corner ... | Class II | Fresenius Kabi USA, LLC |
| Sep 3, 2025 | Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associ... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Assoc... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K1... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: ... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K1... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; A... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K1306... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; A... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K1306... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K13084... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K1020... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K1... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K1... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K1... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associ... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 51... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associa... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 2, 2025 | Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) ... | Due to incorrect product label (Incorrect product name identified on outer packaging). | Class II | Berkeley Advanced Biomaterials, LLC |
| Sep 2, 2025 | Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3... | The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced u... | Class II | LeMaitre Vascular, Inc. |
| Sep 2, 2025 | This device is a digital radiography/fluoroscopy system used in a diagnostic ... | It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the c... | Class II | Canon Medical System, USA, INC. |
| Aug 29, 2025 | CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valve... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, ... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Act... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressi... | Wound dressing may have foreign matter on the product. | Class II | ConvaTec, Inc |
| Aug 29, 2025 | Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F16... | To provide further information to the user to ensure proper use of the medical device. the caps h... | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, thr... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Act... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalo... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standa... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, ... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Ba... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing an... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound minia... | Production assembly error resulting in the potential for reversed articulation, where moving the ... | Class II | ImaCor Inc. |
| Aug 29, 2025 | CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer A... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
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.