Browse Device Recalls
70 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 70 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 70 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 6, 2015 | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use. | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthope... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthope... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. ... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. O... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthope... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthoped... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Or... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONL... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EAC... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EAC... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLA... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONL... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EAC... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONL... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONL... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Apr 30, 2014 | PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Or... | Difficulty removing the cup adaptor from the impaction handle during surgery | Class II | Microport Orthopedics 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.