Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 27, 2012 | Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR m... | Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR F... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 26, 2012 | Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag,... | Surgical procedure trays are packed with pharmaceuticals for injection that may contain particula... | Class II | Custom Healthcare Systems, Inc. |
| Nov 26, 2012 | Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in... | Surgical procedure trays are packed with pharmaceuticals for injection that may contain particula... | Class II | Custom Healthcare Systems, 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 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 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 7, 2012 | Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument... | Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... | Class II | Quanta System, S.p.A. |
| Oct 26, 2012 | Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide... | The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... | Class II | Hospira Inc. |
| Oct 15, 2012 | The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee d... | OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal... | Class II | Ossur Americas, Inc. |
| Oct 10, 2012 | MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ce... | A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 ... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2012 | 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #)... | ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip ... | Class II | ICU Medical, Inc. |
| Sep 28, 2012 | Segmented Cervix Applicator Set, part number GM11004310, a component used wit... | The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect fr... | Class II | Varian Medical Systems, Inc. |
| Sep 21, 2012 | NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The N... | Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component... | Class II | Zimmer, Inc. |
| Sep 20, 2012 | The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non ... | Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the... | Class II | 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.