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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Date	Product	Reason	Class	Firm
Nov 12, 2013	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety...	Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond...	Class II	Ansell Sandel Medical Industries LLC
Nov 12, 2013	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable S...	Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond...	Class II	Ansell Sandel Medical Industries LLC
Nov 11, 2013	Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (...	There is a remote possibility for the plastic latch to deform over the lifetime of use. When thi...	Class II	Sunrise Medical (US) LLC
Nov 11, 2013	Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S ...	Reports of friction within certain instrument arms can interrupt smooth instrument motion. This c...	Class II	Intuitive Surgical, Inc.
Nov 11, 2013	STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low...	Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization...	Class II	Advanced Sterilization Products
Nov 11, 2013	STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a ...	Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization...	Class II	Advanced Sterilization Products
Nov 8, 2013	Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems fo...	Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because...	Class II	Beckman Coulter Inc.
Nov 8, 2013	Video Monitor Suspensions that may be on the following Fluoroscopic and Radio...	Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws t...	Class II	GE Healthcare, LLC
Nov 8, 2013	ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reve...	bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leadin...	Class II	Biomerieux France Chemin De L'Or
Nov 8, 2013	API Listeria (REF 10300) API Listeria is a standardized system for the ide...	bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leadin...	Class II	Biomerieux France Chemin De L'Or
Nov 8, 2013	IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syrin...	Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the ...	Class II	Baxter Healthcare Corp.
Nov 8, 2013	ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : ...	Patient Specific Guide contained the incorrect case report. The case report contains patient spe...	Class II	Materialise USA LLC
Nov 8, 2013	FastPack Free T4 Immunoassay Chemilunescence assay for the determination of...	Qualigen initiated this recall because the FastPack kit may cause lower than expected results due...	Class II	Qualigen Inc
Nov 8, 2013	FastPack Total PSA Immunoassay Chemilunescence assay for the determination ...	Qualigen initiated this recall because the FastPack kit may cause lower than expected results due...	Class II	Qualigen Inc
Nov 8, 2013	SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 243...	CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer becau...	Class II	CareFusion 303, Inc.
Nov 8, 2013	Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usag...	Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada...	Class II	Beckman Coulter Inc.
Nov 8, 2013	VersaSafe Extension Set, Model No. 21000M-007	CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may ...	Class II	CareFusion 303, Inc.
Nov 8, 2013	FastPack Testosterone Immunoassay Chemilunescence assay for the determinati...	Qualigen initiated this recall because the FastPack kit may cause lower than expected results due...	Class II	Qualigen Inc
Nov 8, 2013	API NH (REF 10400) API NH is a standardized system for the identification ...	bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leadin...	Class II	Biomerieux France Chemin De L'Or
Nov 8, 2013	FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescen...	Qualigen initiated this recall because the FastPack kit may cause lower than expected results due...	Class II	Qualigen Inc
Nov 8, 2013	ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : ...	Patient Specific Guide contained the incorrect case report. The case report contains patient spe...	Class II	Materialise USA LLC
Nov 8, 2013	Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Mode...	Potential for a leak between the catheter and the bifurcate which would allow helium to escape to...	Class II	Arrow International Inc
Nov 8, 2013	Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for...	Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because...	Class II	Beckman Coulter Inc.
Nov 8, 2013	Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage...	Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada...	Class II	Beckman Coulter Inc.
Nov 8, 2013	UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for...	Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because...	Class II	Beckman Coulter Inc.
Nov 8, 2013	UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, a...	Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because...	Class II	Beckman Coulter Inc.
Nov 7, 2013	GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiograph...	There exists a software issue associated with patient selection from the worklist on the Optima X...	Class II	GE Healthcare, LLC
Nov 7, 2013	Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher S...	Stryker became aware during laboratory testing that there is a potential that the seal integrity ...	Class II	Stryker Howmedica Osteonics Corp.
Nov 7, 2013	EOS System X- ray beam Digital radiography system used in general radiogra...	EOS imaging discovered during production internal testing that the X-ray beam collimation set up ...	Class II	EOS Imaging
Nov 7, 2013	OrthoPediatrics ACL Reconstruction System is a pediatric and small stature ad...	Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - Nov...	Class II	OrthoPediatrics Corp
Nov 6, 2013	Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Us...	The ADVIA Chemistry software systems using certain software versions allows the system to automat...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 6, 2013	Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-10...	When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software vers...	Class II	Data Innovations, Inc.
Nov 6, 2013	IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 ...	potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000...	Class II	Siemens Healthcare Diagnostics
Nov 6, 2013	Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatolo...	Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch an...	Class II	Candela Corporation
Nov 6, 2013	Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeo...	KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper w...	Class II	Karl Storz Endoscopy America Inc
Nov 5, 2013	DIST LAT FEM LOCK PLT, LT	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Nov 5, 2013	ITST THREADED GUIDE PIN	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Nov 5, 2013	FEM COND BUTTRESS PLT, RT.	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Nov 5, 2013	TIBIO FEM/FEM NAIL.	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Nov 5, 2013	Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M00625022...	The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ...	Class II	Boston Scientific Corporation
Nov 5, 2013	Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M006250228...	The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ...	Class II	Boston Scientific Corporation
Nov 5, 2013	TIB NAIL	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Nov 5, 2013	FEM COND BUTTRESS PLT, LT	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Nov 5, 2013	DIST LAT FEM LOCK PLT, RT	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Nov 5, 2013	NGK Stem Ext 24 x 245mm	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Nov 5, 2013	SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System...	ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the mini...	Class II	ASI Medical, Inc.
Nov 5, 2013	Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M006250228...	The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ...	Class II	Boston Scientific Corporation
Nov 4, 2013	Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap;...	There is a potential that the specified mucus specimen traps are not sterile. Use of the affected...	Class II	Medline Industries Inc
Nov 4, 2013	Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940...	Products were shipped labeled with "use by" dates that exceed currently available shelf-life data...	Class II	Stryker Neurovascular
Nov 4, 2013	LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip ...	Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver...	Class II	Lanx, 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.