Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Jan 4, 2017 ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Pro... DHEA-S causes falsely elevated progesterone results. Class II Siemens Healthcare Diagnostics, Inc
Jan 4, 2017 Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Nu... DHEA-S causes falsely elevated progesterone results. Class II Siemens Healthcare Diagnostics, Inc
Jan 4, 2017 Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system i... Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix D... Class II Baxter Healthcare Corporation
Jan 4, 2017 Vanguard Total Knee System Vanguard Open Box Femoral Components Item Numb... packaging of some femoral components was incorrectly labeled as either smaller or larger and/or a... Class II Zimmer Biomet, Inc.
Jan 4, 2017 AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA... Endologix updated information on the rates of Type III endoleaks and suggestions for patient surv... Class II Endologix
Jan 4, 2017 IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material... DHEA-S causes falsely elevated progesterone results. Class II Siemens Healthcare Diagnostics, Inc
Jan 4, 2017 IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material... DHEA-S causes falsely elevated progesterone results. Class II Siemens Healthcare Diagnostics, Inc
Jan 3, 2017 Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usag... During use, there is a potential scenario which could allow the fastening screws attaching covers... Class II Allen Medical Systems, Inc.
Jan 3, 2017 QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain ... An incorrect sterility status on the label, non-sterile products labeled as sterile Class II Stryker Leibinger GmbH & Co. KG
Jan 3, 2017 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar ... An incorrect sterility status on the label, non-sterile products labeled as sterile Class II Stryker Leibinger GmbH & Co. KG
Jan 1, 2017 Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 50705... Potential performance issue on strain categorization. Class II BioMerieux SA
Jan 1, 2017 Standex International Bakers Pride Microwave Ovens Model E300 It was discovered that all five microwave ovens fail to have concealed or inaccessible safety int... Class II Standex Intl Corp
Jan 1, 2017 Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, ... The microscope may tip over if attachments are fully extended in one line and there is an attempt... Class II Seiler Instr. & Mfg. Co. 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.