Browse Device Recalls

5,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,428 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 5,428 FDA device recalls.

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DateProductReasonClassFirm
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
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-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, B.40, 3D I USB-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-ML04, 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 USB-ML05, 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 IND USB-ML 02, 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, B.40 Dualt-ML, Industry instrument softw... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 4, 2012 Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a met... The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) Class II Biomet, Inc.
Oct 3, 2012 STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validat... Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological In... Class II Advanced Sterilization Products
Oct 2, 2012 Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Commun... GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the... Class II GE Healthcare It
Sep 28, 2012 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the ac... A product complaint was received where a size 20 screw was labeled as size 30. After receipt, mea... Class II Encore Medical, Lp
Sep 26, 2012 DeGotzen XRay unit XGenus Dental X-ray unit. It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certi... Class II DeGotzen
Sep 20, 2012 STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are... Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it... Class II Advanced Sterilization Products
Sep 19, 2012 Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is d... The firm initiated the product recall because labeling on some of the intermediate boxes of cathe... Class II Cure Medical LLC
Sep 11, 2012 Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 P... Philips was notified that when performing post processing with the Brilliance Workspace Portal pl... Class II Philips Medical Systems (Cleveland) Inc
Sep 7, 2012 Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped ... Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "Th... Class II Optovue 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.