Browse Device Recalls
2,549 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,549 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 2,549 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 4, 2013 | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... | Class I | DePuy Orthopaedics, Inc. |
| Jan 4, 2013 | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... | Class I | DePuy Orthopaedics, Inc. |
| Jan 4, 2013 | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... | Class I | DePuy Orthopaedics, Inc. |
| Jan 4, 2013 | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... | Class I | DePuy Orthopaedics, Inc. |
| Jan 3, 2013 | TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manu... | Thru hole at the tip of the screw is undersized. | Class II | Biomet, Inc. |
| Dec 6, 2012 | Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling... | Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been... | Class II | Hill-Rom, Inc. |
| Dec 3, 2012 | SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protect... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly prote... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly prote... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly prote... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly prote... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Nov 28, 2012 | Pinnacle Cancellous Screw Packaging: Product is housed within a polyuretha... | DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle¿ Cancellous Sc... | Class II | DePuy Orthopaedics, Inc. |
| Nov 19, 2012 | Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic ana... | A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener ... | Class III | Roche Diagnostics Operations, Inc. |
| Nov 19, 2012 | Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regula... | Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inn... | Class II | Zimmer, Inc. |
| Nov 19, 2012 | COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS ... | Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inn... | Class II | Zimmer, Inc. |
| Nov 15, 2012 | Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Produ... | Biomet investigation identified that the square end of the offset tibial tray adaptor locking ins... | Class II | Biomet, Inc. |
| Nov 14, 2012 | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Cobas b 123 POC system cobas b 123 POC system is fully automated POC syste... | It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 214... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 m... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, ... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, ... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diame... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, ... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 12, 2012 | Zimmer Spine Ardis Inserter, Rx, non-sterile | Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when... | Class I | Zimmer, 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.