Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

Clear
DateProductReasonClassFirm
Nov 14, 2012 Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test ... Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... Class II Siemens Healthcare Diagnostics, Inc
Nov 14, 2012 Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit... Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... Class II Siemens Healthcare Diagnostics, 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 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... This notice is being provided in follow up to the field correction initiated by B. Braun Medical ... Class I B Braun Medical, Inc.
Nov 14, 2012 Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The AD... Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room ... Class II Siemens Healthcare Diagnostics, 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 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced... Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a... Class II Terumo Cardiovascular Systems Corporation
Nov 14, 2012 Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system ... Due to a problem with the control software of the x-ray high-voltage generator, if scanning is pe... Class II Toshiba American Medical Systems Inc
Nov 14, 2012 Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 1049137... Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room ... Class II Siemens Healthcare Diagnostics, 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 Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 090464... Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... Class II Siemens Healthcare Diagnostics, 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 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced... Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced ... Class II Terumo Cardiovascular Systems Corporation
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 Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Tr... RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining i... Class II Leica Microsystems, 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 14, 2012 Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 ... Operating range of the ADVIA Centaur systems is 18C¿ to 30¿C (64.4¿F to 86.0¿F), a change in room... Class II Siemens Healthcare Diagnostics, Inc
Nov 13, 2012 Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissu... The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the ... Class II Leica Microsystems, Inc.
Nov 13, 2012 The Vertex Max Drill Tube is a component within the Navigated Vertex Max Dril... Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation Syst... Class II Medtronic Navigation, Inc.
Nov 12, 2012 BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Ster... BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to ex... Class II Becton Dickinson & Company
Nov 12, 2012 SpineSix consists of a motorized treatment table that is controlled by an int... BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02... Class II BioMotion Medical Systems, LLC
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.
Nov 12, 2012 Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog... Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guid... Class II Greatbatch Medical
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 10, 2012 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Nov 9, 2012 Philips IntelliVue Information Center/Client and Philips IntelliVue Informati... Internal audio cable may have diminished retention force due to damaged contacts, which could lea... Class II Philips Healthcare Inc.
Nov 9, 2012 AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses The lenses exceeded the acceptance limit for silicone oil residual. Class II Cooper Vision Caribbean Corp.
Nov 9, 2012 Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in ... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 9, 2012 EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail S... It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel... Class II Biomet, Inc.
Nov 9, 2012 Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A ... Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or be... Class II SpineFrontier, 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.