Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

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DateProductReasonClassFirm
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548700 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548870 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548780 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Ca... One complaint of a seat on a scale failing unexpectedly which can cause an injury. Class II Cardinal Scale Mfg Co
Dec 23, 2015 Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instruct... Class II Stryker Howmedica Osteonics Corp.
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548550 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548630 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power ... The sterile battery may contain particulates within the sterile package. Class II Pro-Dex Inc
Dec 23, 2015 GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System ... Potential safety latch mechanism failure. The safety latch, within the column that supports the ... Class II GE Medical Systems, LLC
Dec 23, 2015 Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleani... This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548590 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548760 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548490 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00549380 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Des... Potential safety latch mechanism failure. The safety latch, within the column that supports the ... Class II GE Medical Systems, LLC
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00549430 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548400 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548860 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548390 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548520 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-005... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548610 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548580 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548710 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices Inc
Dec 23, 2015 EndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-00... A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... Class II Xeridiem Mediem Medical Devices 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.