Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
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 21, 2012 Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mc... Boxes labeled as CIP5 may contain cartridges of AMP5. Class III Remel Inc
Nov 19, 2012 Patient Circuit used with the Life Pulse High Frequency Ventilator. The Pati... Customer complaints received indicate the heater wire insulation can melt, causing a short which ... Class I Bunnell, Inc.
Nov 16, 2012 DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DeP... Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labele... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 15, 2012 EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk... Class II EEG Info
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 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 8, 2012 Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescr... The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in... Class II Medline Industries Inc
Nov 6, 2012 BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton,... An antibiotic susceptibility test kit may produce false intermediate or false resistant results w... Class II Becton Dickinson & Co.
Nov 5, 2012 Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, ... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, Inc.
Nov 5, 2012 Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMW... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, Inc.
Oct 26, 2012 Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An... Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling ... Class II Beckman Coulter Inc.
Oct 25, 2012 Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Br... Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar M... Class II Quasar Bio-Tech, Inc. dba Silver Bay LLC
Oct 25, 2012 Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are... Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar M... Class II Quasar Bio-Tech, Inc. dba Silver Bay LLC
Oct 25, 2012 Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is ... Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar M... Class II Quasar Bio-Tech, Inc. dba Silver Bay LLC
Oct 24, 2012 Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #88... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, ... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, ... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 22, 2012 BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fif... In vitro diagnostic test kit was not manufactured according to specifications and may cause false... Class II Becton Dickinson & Co.
Oct 19, 2012 Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endo... Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompa... Class II TITAN SPINE, LLC
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument T... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrum... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, ... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrumen... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrum... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instr... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrum... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB up... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, US... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument ... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux 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.