Browse Device Recalls

1,506 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,506 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 1,506 FDA device recalls in FL.

Clear
DateProductReasonClassFirm
Jul 29, 2015 UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous de... MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexe... Class II Biomet 3i, LLC
Jul 16, 2015 Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking ... The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. Class II Mako Surgical Corporation
Jul 1, 2015 Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical p... Saw head separated from the drive unit or began to come loose. Class II The Anspach Effort, Inc.
Jun 10, 2015 Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed ... Class II ASO, LLC
May 26, 2015 Bausch & Lomb SofPort Advanced Optics Aspheric Lens Haptics breaking during lens loading and insertion. Class II Bausch & Lomb Surgical, Inc.
May 26, 2015 Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofP... Haptics breaking during lens loading and insertion. Class II Bausch & Lomb Surgical, Inc.
May 21, 2015 Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical ... Shipped to a single consignee prior to completion of final inspection. Class II Exactech, Inc.
May 21, 2015 Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpo... Shipped to a single consignee prior to completion of final inspection. Class II Exactech, Inc.
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Produ... Failures of the splice repair kit if exposed to excessive force. Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac tr... Complaints with the HVAD Abnormal Power Source Switching. Class II HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 ... Complaints with the HVAD Internal Controller Alarm Battery failures. Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / ... HeartWare has received complaints relating to damage or bent connection pins within the power sup... Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 110... Complaints with the HVAD Retraction of Pins within the driveline connector. Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac tra... Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath. Class II HeartWare Inc
Apr 13, 2015 ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shapi... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bon... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting sh... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. C... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cut... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cut... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bon... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bo... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone ... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting sha... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting ... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutti... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including ... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shapin... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cu... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 ... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting ... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including sp... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting ... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shapin... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting sh... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bo... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting sh... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cu... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone ... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 2, 2015 Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncol... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., 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.