Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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DateProductReasonClassFirm
Jun 6, 2013 BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 2... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375,... Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incuba... Class II Ortho-Clinical Diagnostics
Jun 6, 2013 BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in carton... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. ... Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tiss... Class II Endogastric Solutions Inc
Jun 6, 2013 AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal de... The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complet... Class II Sybron Dental Specialties
Jun 6, 2013 Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images. Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System du... Class II Carestream Health, Inc.
Jun 6, 2013 BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog #... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 5, 2013 PANTERA Proximal Humerus Fracture Plate System Potential suture clip breaking during a humerus fixation surgery. Class II Toby Orthopaedics, Inc.
Jun 5, 2013 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Cro... 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 cont... Class III 3M Company - Health Care Business
Jun 5, 2013 5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit ... DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. T... Class II Synthes USA HQ, Inc.
Jun 5, 2013 Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab... The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presen... Class II Fisher Scientific Co
Jun 5, 2013 Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003.... Siemens issued a Field Safety Notice about the potential hazard to patients or operators when usi... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2013 Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass C... Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dis... Class II Siemens Healthcare Diagnostics, Inc.
Jun 4, 2013 Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Over... Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the ex... Class II Terumo Cardiovascular Systems Corporation
Jun 4, 2013 Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disp... Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due ... Class II Utah Medical Products, Inc
Jun 4, 2013 Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 1... Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue wit... Class I Respironics California Inc
Jun 4, 2013 Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in d... Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently deter... Class II Mesa Laboratories, Inc., Bozeman Manufacturing ...
Jun 4, 2013 ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system t... Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complem... Class II Baxa Corporation
Jun 4, 2013 Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended fo... Self-contained steam biological indicator, are recalled because Mesa recently determined that the... Class II Mesa Laboratories, Inc., Bozeman Manufacturing ...
Jun 4, 2013 Invacare Power Wheelchair, one per box To provide mobility to a person res... Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended accelerat... Class II Invacare Corporation
Jun 3, 2013 Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert O... Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the spon... Class II Alere San Diego, Inc.
Jun 3, 2013 Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... Class I Medtronic Neuromodulation
Jun 3, 2013 CMC Saddle Product Usage: The Ascension CMC is intended to resurface the ... As a result of a quality review, labelling content discrepancies were identified between the Inst... Class III Integra LifeSciences Corp.
Jun 3, 2013 Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm c... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system i... Due to potential for an x-ray exposure technique change. Class II Carestream Health Inc.
Jun 3, 2013 Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... Medtronic is providing Healthcare Professionals with important safety information and patient man... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... Medtronic is providing Healthcare Professionals with important safety information and patient man... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Cont... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Soft... The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyz... Class II Beckman Coulter Inc.
Jun 3, 2013 Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: cat... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 ... Cassette may leak during set up or during peritoneal dialysis treatment Class II Fresenius Medical Care Holdings, Inc.
Jun 3, 2013 Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segm... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
May 31, 2013 BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, use... Electrical power module installed on some in vitro diagnostic instruments does not meet industry ... Class III Becton Dickinson & Co.
May 31, 2013 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... Class II Karl Storz Endoscopy America Inc
May 31, 2013 Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding ... Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbe... Class II Synthes USA HQ, Inc.
May 31, 2013 Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Acce... Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE S... Class II Greatbatch Medical
May 31, 2013 Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting... The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column ... Class II Synthes (USA) Products LLC
May 30, 2013 TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complet... When the bed is put into the chair egress position, the magnets on the mattress may not hold the... Class II Hill-Rom, Inc.
May 30, 2013 ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irr... Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Co... Class II Linvatec Corp. dba ConMed Linvatec
May 30, 2013 ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for j... Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Co... Class II Linvatec Corp. dba ConMed Linvatec
May 30, 2013 Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long... Stryker has received reports from customers indicating post-operative fracture of the pin that c... Class I Stryker Spine
May 30, 2013 Exactech Articulated Driver A nonpowered hand-held device intended for me... When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift ou... Class II Exactech, Inc.
May 30, 2013 Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Co... Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled hea... Class II Terumo Cardiovascular Systems Corporation
May 30, 2013 Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Use... Medical devices were incorrectly labeled with extended expiration dates. Class II Terumo Medical Corporation
May 30, 2013 GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE ... DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem wi... Class II DeRoyal Industries Inc
May 30, 2013 Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Ti... Medical devices were incorrectly labeled with extended expiration dates. Class II Terumo Medical Corporation

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.