Browse Device Recalls
1,516 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,516 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 1,516 FDA device recalls in FL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 27, 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner... | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... | Class II | Nipro Medical Corporation |
| Jul 27, 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hy... | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... | Class II | Nipro Medical Corporation |
| Jul 27, 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner... | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... | Class II | Nipro Medical Corporation |
| Jul 25, 2012 | Myocardial Heart Wires Intended for temporary atrial and ventricular pacin... | Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C... | Class II | Oscor, Inc. |
| Jul 10, 2012 | Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 344... | Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The rec... | Class II | Winco Mfg., LLC |
| Jul 10, 2012 | Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***... | Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The rec... | Class II | Winco Mfg., LLC |
| Jul 9, 2012 | Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and p... | On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a du... | Class II | Apheresis Technologies, Inc. |
| Jul 6, 2012 | PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConM... | ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diamete... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Jun 26, 2012 | "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CON... | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Jun 26, 2012 | "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***... | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Jun 26, 2012 | "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CO... | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Jun 26, 2012 | "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CON... | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Jun 26, 2012 | NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 US... | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Jun 26, 2012 | "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***... | Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items ... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Jun 20, 2012 | Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 an... | Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because t... | Class II | Gulf South Medical Supply Inc |
| Jun 15, 2012 | Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 15, 2012 | Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total ... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 15, 2012 | Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total ... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 15, 2012 | Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Revers... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 15, 2012 | Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Tot... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 15, 2012 | Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine interver... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 11, 2012 | Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutt... | Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a ca... | Class II | The Anspach Effort, Inc. |
| Jun 11, 2012 | Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome.... | Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a ca... | Class II | The Anspach Effort, Inc. |
| May 31, 2012 | Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is l... | Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due ... | Class II | Biomet 3i, LLC |
| May 23, 2012 | Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instru... | On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due ... | Class II | Stingray Surgical Products, LLC |
| May 7, 2012 | US-001 Rev A brochure is a two sided tri-fold printed marketing brochure desc... | Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which c... | Class II | Non-Invasive Monitoring Systems, Inc. |
| May 7, 2012 | USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure des... | Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which c... | Class II | Non-Invasive Monitoring Systems, Inc. |
| Apr 10, 2012 | "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATE... | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cann... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Apr 10, 2012 | "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVA... | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cann... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Apr 9, 2012 | GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-R... | The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm'... | Class II | Gulf Fiberoptics, Inc. |
| Apr 9, 2012 | "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 1... | ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect ... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Mar 29, 2012 | MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. ... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping del... | Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details ... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. In... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are includ... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, 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.