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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.