Browse Device Recalls

34,180 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,180 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 34,180 FDA device recalls — Class II.

Clear
DateProductReasonClassFirm
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
Aug 29, 2025 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer A... IV sets may leak. Class II Baxter Healthcare Corporation
Aug 29, 2025 CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, C... IV sets may leak. Class II Baxter Healthcare Corporation
Aug 29, 2025 Getinge 88-Series Washer- Disinfector. Model Number: 88-5. Potential for device to overheat during operation if the circulation pressure calibration was not... Class II Getinge Disinfection Ab
Aug 29, 2025 NES Reprocessed 2.0mm 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 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two... IV sets may leak. Class II Baxter Healthcare Corporation
Aug 29, 2025 The product is a handheld ultraviolet-C germicidal wand and contains a narrow... The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure l... Class II BigTree Sales Inc.
Aug 29, 2025 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer A... IV sets may leak. Class II Baxter Healthcare Corporation
Aug 29, 2025 NES Reprocessed 2.0mm 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 NES Reprocessed 1.7mm 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 CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 d... IV sets may leak. Class II Baxter Healthcare Corporation
Aug 28, 2025 Sharesource Connectivity Platform for Use with Homechoice Claria Product C... Vantive has identified a software defect within the Sharesource Claria software, which may cause ... Class II Vantive US Healthcare LLC
Aug 28, 2025 Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12m... The product in incorrectly labeled. The label indicates that the skive hole should be above the b... Class II Boston Scientific Corporation
Aug 28, 2025 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V4... a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may c... Class II Howmedica Osteonics Corp.
Aug 27, 2025 The AlignRT InBore system contains six Class 1 lasers which enables the syste... Vision RT is informing customers of an omission identified in the Instructions for Use for AlignR... Class II Vision RT Ltd
Aug 26, 2025 GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH0500... Reports of vascular graft delamination, which may lead to reduced access flow; cannulation diffic... Class II W L Gore & Associates, Inc.
Aug 26, 2025 Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... Class II OSSTEM Implant Co., Ltd.
Aug 26, 2025 Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... Class II OSSTEM Implant Co., Ltd.
Aug 26, 2025 Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... Class II OSSTEM Implant Co., Ltd.
Aug 25, 2025 Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636... Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet a... Class II LeMaitre Vascular, Inc.
Aug 22, 2025 Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breath... One lot manufactured with an invalid sterilization cycle. Class II CooperVision, Inc.
Aug 22, 2025 Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 ... Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dro... Class II Sonesta Medical AB
Aug 22, 2025 MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multic... If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can re... Class II GE Medical Systems, LLC
Aug 22, 2025 Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant... One lot manufactured with an invalid sterilization cycle. Class II CooperVision, Inc.
Aug 22, 2025 MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. ... One lot manufactured with an invalid sterilization cycle. Class II CooperVision, Inc.
Aug 21, 2025 i-STAT EG7+ cartridge. List Number: 03P76-25. Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... Class II Abbott Point Of Care Inc.
Aug 21, 2025 Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 21, 2025 Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to iden... Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification featu... Class II Bard Peripheral Vascular Inc
Aug 21, 2025 Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 21, 2025 Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , R... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 21, 2025 i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K... Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... Class II Abbott Point Of Care Inc.
Aug 21, 2025 Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 21, 2025 i-STAT CG4+ cartridge (white). List Number: 03P85-25. Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type... Class II Abbott Point Of Care Inc.

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.