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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
Oct 11, 2013 GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasoun... GE became aware of a potential safety issue due to a system slow down and system lock up associat... Class II GE Healthcare, LLC
Oct 11, 2013 COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541,... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ASIA ONE-PIECE LAG SCREW Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ZIMTRON 6 DEG 22 HEADS Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIU... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item co... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 00... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 CPT 12/14 COCR (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENE... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube o... Incorrect instructions for use (IFU). Class I Codman & Shurtleff, Inc.
Oct 11, 2013 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SEL... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 PRESSFIT FEM ST FX 16 X 1 Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRU... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELF... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 10, 2013 The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed ... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 ... Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, a... Class II Mizuho America, Inc.
Oct 10, 2013 Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usa... Investigation identified that the design of the drill bit may make the suture anchor difficult to... Class II Biomet, Inc.
Oct 10, 2013 Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent ... Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, a... Class II Mizuho America, Inc.
Oct 10, 2013 The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, ... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 VariAx Compression Plating System Stryker received two reports indicating that during screw insertion under a high lateral angle a ... Class II Stryker Howmedica Osteonics Corp.
Oct 10, 2013 The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene S... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chem... Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing C... Class II Ortho-Clinical Diagnostics
Oct 10, 2013 The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactat... Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell le... Class II Nova Biomedical Corporation
Oct 10, 2013 Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro... A review of complaints identified a trend for drills breaking. Class II Cayenne Medical Inc.
Oct 9, 2013 VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/... Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic P... Class II Ortho-Clinical Diagnostics
Oct 9, 2013 Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is use... A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Oste... Class II Synthes USA HQ, Inc.
Oct 9, 2013 GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Inten... There is an issue with the Manual Film Composer feature on some CT products. There is an opportu... Class II GE Healthcare, LLC
Oct 9, 2013 Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, ... Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.... Class II Zimmer, Inc.
Oct 9, 2013 Arrow Transradial Artery Access products Arrow Transradial Artery Access p... There is a risk that the introducer needles packaged within the kits can be partially or fully oc... Class II Arrow International Inc
Oct 9, 2013 Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripher... A labeling inconsistency was discovered in which the lidstock states that the kit contains a stim... Class II Arrow International Inc
Oct 9, 2013 Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX NT2000iX software shipped with the international setting turned on. The international settings in... Class II Neurotherm, Inc.
Oct 8, 2013 enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5... Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen S... Class II Ortho-Clinical Diagnostics
Oct 8, 2013 enGen Track System with enGen Select v5.0 with autoverification enabled Pr... Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen S... Class II Ortho-Clinical Diagnostics
Oct 8, 2013 Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for S... Complaints were received which described the SynFix LR implant holder breaking at the interface b... Class II Synthes USA HQ, Inc.
Oct 7, 2013 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on... In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the p... Class II Baxter Healthcare Corp.
Oct 7, 2013 Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) P... Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the ... Class II Mindray DS USA, Inc. dba Mindray North America
Oct 7, 2013 GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. ... Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. Class II Smith & Nephew Inc
Oct 7, 2013 Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Sten... A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Co... Class II Medtronic Vascular, Inc.
Oct 7, 2013 CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP iso... Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso ... Class II LAP of America Laser Applications, LLC
Oct 7, 2013 User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension ... When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the syste... Class II Siemens Healthcare Diagnostics, Inc.
Oct 7, 2013 GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188.... Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. Class II Smith & Nephew Inc
Oct 7, 2013 C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12... As the result of a recent internal review of regulatory documents, we have determined that the 10... Class II RTI Surgical, 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.