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
Nov 4, 2013 Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M003168191... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Prod... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is ... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product i... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M003168190... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single u... Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor... Class II Stryker Instruments Div. of Stryker Corporation
Nov 4, 2013 Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Pro... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product i... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Produ... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Pro... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 ... The patient label associated with the product may be incorrect in that the lot number on the pati... Class II Zimmer, Inc.
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 1, 2013 Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx onl... It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male ... Class II SALTER LABS
Nov 1, 2013 Acetabular Pressurizer; single use and six units per box. The Acetabular P... On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer ... Class II Stryker Instruments Div. of Stryker Corporation
Oct 31, 2013 Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infus... Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly... Class I Hospira Inc.
Oct 31, 2013 Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions incl... Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Enc... Class I Hospira Inc.
Oct 31, 2013 NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Ti... Two complaints were received in which it was reported that the stem would not lock into the tibia... Class II Zimmer, Inc.
Oct 30, 2013 The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised tita... The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the po... Class II ACUTE Innovations, LLC
Oct 30, 2013 Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The... Under extremely rare circumstances, a patient result that had been previously disabled may be rel... Class II Siemens Healthcare Diagnostics, Inc.
Oct 30, 2013 Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LL... Maquet has received an increase in the number of complaints for "self-activated/remains activated... Class II Maquet Cardiovascular, LLC
Oct 30, 2013 Easy Diagnost Eleva Universal Fluoroscopic applications The delivered application software was an outdated version to the model of equipment. Class II Philips Medical Systems, Inc.
Oct 30, 2013 Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #... The lift might fail with the labeled 500-lb. load rating. Class II Ergosafe Products LLC DBA Prism Medical Service...
Oct 30, 2013 Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. ... The lift might fail with the labeled 500-lb. load rating. Class II Ergosafe Products LLC DBA Prism Medical Service...
Oct 29, 2013 Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Ac... Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated... Class II Kimberly-Clark Corporation
Oct 29, 2013 MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed)... Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet ... Class III Thermofisher Scientive
Oct 29, 2013 Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Tit... There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fractu... Class II Orthofix, Inc
Oct 28, 2013 Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system. Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absor... Class II Toshiba American Medical Systems Inc
Oct 28, 2013 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros ... Promotional materials for non-medical water filtration products were determined to promote claims... Class I Nephros Inc
Oct 28, 2013 TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of t... The coupler point (hood) of the Leg Section One Part Light may become detached from the leg secti... Class II Trumpf Medical Systems, Inc.
Oct 28, 2013 Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 0854... Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential t... Class II Abbott Point Of Care Inc.
Oct 28, 2013 Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient c... Reports of loose bolts in the detector support structure of Symbia and E.CAM systems. Class II Siemens Medical Solutions USA, Inc.
Oct 28, 2013 Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura sub... Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD ... Class II Synovis Surgical Innovations, Inc.
Oct 28, 2013 Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Numbe... Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesi... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Oct 28, 2013 Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ... Promotional materials for non-medical water filtration products were determined to promote claims... Class I Nephros Inc
Oct 28, 2013 e.cam line of gamma camera systems Used to detect or image the distributi... Reports of loose bolts in the detector support structure of Symbia and e.cam systems. Class II Siemens Medical Solutions USA, Inc.
Oct 28, 2013 Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: ... Promotional materials for non-medical water filtration products were determined to promote claims... Class I Nephros Inc
Oct 28, 2013 Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product cont... Package labeling indicates both "latex free" and "contains natural rubber latex" . The rubber ba... Class II Centurion Medical Products Corporation
Oct 28, 2013 Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in pe... Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD ... Class II Synovis Surgical Innovations, Inc.
Oct 25, 2013 ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva C... There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when th... Class II Roche Diagnostics Operations, Inc.
Oct 25, 2013 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Ang... Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was iden... Class II Stryker Howmedica Osteonics Corp.
Oct 25, 2013 GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo ... GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan proce... Class II GE Healthcare, LLC
Oct 25, 2013 REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /... Security Blades were manufactured oversized and potentially won't advance or may be difficult to ... Class II Biomet, 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.