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Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

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DateProductReasonClassFirm
Dec 1, 2015 Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN... The firm became aware of cases in which the battery run times of the optional PS 500 power supply... Class I Draeger Medical, Inc.
Dec 1, 2015 SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexi... The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual di... Class II Synthes (USA) Products LLC
Dec 1, 2015 MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Posit... Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... Class II Beckman Coulter Inc.
Dec 1, 2015 PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy s... Damage to package seals potentially compromising sterility. Class II JosNoe Medical, Inc.
Dec 1, 2015 MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan... Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... Class II Beckman Coulter Inc.
Dec 1, 2015 QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets ... The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164... Class II Microbiologics Inc
Dec 1, 2015 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M... Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. Thi... Class II 3M Company - Health Care Business
Dec 1, 2015 UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Pa... Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... Class II Beckman Coulter Inc.
Nov 30, 2015 Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: F... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Nov 30, 2015 GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0... Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due... Class II Verathon, Inc.
Nov 30, 2015 Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Nov 30, 2015 Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, ... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Nov 30, 2015 BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U27... The firm is providing customers with an updated Operations and Maintenance Manual for each of the... Class II Verathon, Inc.
Nov 30, 2015 GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-... Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due... Class II Verathon, Inc.
Nov 30, 2015 Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is us... Contamination of product with possible Bacillus spp Class II Acumedia Manufacturers, Inc.
Nov 30, 2015 Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDR... The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tub... Class II Bayer Healthcare
Nov 30, 2015 Columbus Revision Knee System, EnduRo Knee System Product Usage: The Colu... Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem impla... Class II Aesculap, Inc.
Nov 27, 2015 Bond Polymer Refine Red Detection DS9390 kits. The common name of the device ... The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred d... Class II Leica Microsystems, Inc.
Nov 25, 2015 Gold -Tite Hexed Retaining Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Extra Light Retention Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Hex Try-in Screw (5 pk) Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Preformance Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Cover Screw, Headless Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Provide Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Extra Light Angled Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Temporary Non-Hexed Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Pick-Up Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Pick-Up Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Implant EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 DAL-RO Threaded Female Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Conical Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain IOL Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical EP Pick-Up Coping (Non-Hexed) Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Prep-tite Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Implant Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Replacement Housing Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Abutment Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Implant Straight Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical Healing Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Twist Lock TM Straight Transfer Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Index Coping Surgical Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Locator Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental ... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Standard Abutment Temporary Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC

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.