Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls.

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DateProductReasonClassFirm
Oct 25, 2012 Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers... When the operator for a wall stand view selects an "image rotation" different from default, or su... Class II Philips Healthcare Inc.
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 Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. O... When the MC-500 is turned on and coagulation is performed without changing the laser color, the d... Class II Nidek 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 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 11, 2012 COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Auto... Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection... Class II Roche Molecular Systems, Inc.
Oct 9, 2012 Digital RID Plate Reader and Software Product Code: AD400 If a control ring is marked after reading, the software will not flag results that are out of the... Class II The Binding Site Group, Ltd.
Oct 5, 2012 Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), ... Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection softwa... Class II Philips Medical Systems (Cleveland), Inc.
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 Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model ... Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to s... Class II Philips Medical Systems (Cleveland) Inc
Sep 28, 2012 Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomograp... Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the E... Class II Philips Medical Systems (Cleveland) Inc
Sep 21, 2012 Diamigo i-Phone App The Diamigo app was intended for use as an educationa... Diamigo, a software application, was released through the i-Phone Global Store which inadvertentl... Class II sanofi-aventis US, Inc.
Sep 20, 2012 ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTR... Class II Horiba Instruments, Inc dba Horiba Medical
Sep 14, 2012 Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4... InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical ... Class II Hologic, Inc.
Sep 14, 2012 Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1an... Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may b... Class II Hologic, Inc.
Sep 12, 2012 The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is inten... MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software ... Class II Mako Surgical Corporation
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 3, 2012 UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel... Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment proce... Class II Beckman Coulter 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.