Browse Device Recalls

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

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DateProductReasonClassFirm
Mar 6, 2013 CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used... Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode... Class II Roche Diagnostics Operations, Inc.
Mar 1, 2013 Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog n... Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir... Class II Roche Diagnostics Operations, Inc.
Feb 26, 2013 TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered ... In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead... Class II Hill-Rom, Inc.
Feb 25, 2013 ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular... The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to ... Class II DePuy Orthopaedics, Inc.
Feb 25, 2013 GOPump Elastometric infusion PumpKit with/ and without accesssories all conta... Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became... Class I Symbios Medical Products, LLC
Feb 14, 2013 Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter ass... The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting b... Class II Zimmer, Inc.
Feb 10, 2013 ROSA Surgical Device 2.5.8 Issue with optional neuro-endoscopy module detected under specific conditions during internal tes... Class II Zimmer Biomet, Inc.
Feb 8, 2013 Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part ... Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a s... Class II Zimmer, Inc.
Feb 5, 2013 Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma ... Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance... Class II DePuy Orthopaedics, Inc.
Feb 5, 2013 REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Ortho... The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of... Class II Biomet, Inc.
Feb 5, 2013 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled el... Observed instability of the device. Class II Zimmer Biomet, 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 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.

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.