Browse Device Recalls

1,023 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,023 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 1,023 FDA device recalls — Class III.

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Date	Product	Reason	Class	Firm
Aug 7, 2012	ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652...	ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t...	Class III	Siemens Healthcare Diagnostics, Inc
Aug 3, 2012	Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is ...	Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent ...	Class III	Siemens Healthcare Diagnostics, Inc.
Aug 2, 2012	PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test ...	Customers were not following the labeled assay procedure. This was due to a letter issued to them...	Class III	Phadia US Inc
Aug 2, 2012	100 ft roll of tubing inside a cardboard box. Medical devices are sealed into...	On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it ...	Class III	Steris Corporation
Jul 31, 2012	cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecula...	It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packag...	Class III	Roche Molecular Systems, Inc.
Jul 23, 2012	VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek Sys...	Review of instrument software databases and investigation of two customer reports determined that...	Class III	Trek Diagnostic Systems
Jul 20, 2012	TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medica...	Product is missing the label on the internal packaging.	Class III	Teleflex Medical
Jul 19, 2012	Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06...	Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control ...	Class III	Abbott Point Of Care Inc.
Jul 17, 2012	Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K408...	Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) r...	Class III	Siemens Healthcare Diagnostics, Inc.
Jul 10, 2012	Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual...	Defective camera: There is a possibility that the connection of the wires to the connector may be...	Class III	Berchtold Corp.
Jul 9, 2012	IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics pa...	The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control,...	Class III	Iris Diagnostics
Jun 20, 2012	System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 ...	During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sa...	Class III	Terumo Cardiovascular Systems Corporation
Jun 19, 2012	STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX steri...	Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys...	Class III	Advanced Sterilization Products
Jun 19, 2012	STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX ste...	Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys...	Class III	Advanced Sterilization Products
Jun 7, 2012	Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley Cit...	Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadve...	Class III	Integra LifeSciences Corp. d.b.a. Integra Pain ...
Jun 7, 2012	Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502...	Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058...	Class III	Siemens Healthcare Diagnostics, Inc.
May 29, 2012	Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code...	The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as run...	Class III	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Apr 24, 2012	The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic br...	The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicus...	Class III	Ormco/Sybronendo
Apr 23, 2012	SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. P...	Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIG...	Class III	Sigma
Mar 30, 2012	Model 324JL On-Board Suction System Intended use: On-board suction system f...	A shipment mix-up took place.	Class III	Impact Instrumentation, Inc.
Mar 28, 2012	Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, S...	St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which w...	Class III	St Jude Medical Inc
Mar 22, 2012	PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ...	Class III	Tripath Imaging, Inc.
Mar 22, 2012	PrepStain Syringing Pipettes 240 (Catalog #490517)	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ...	Class III	Tripath Imaging, Inc.
Mar 22, 2012	PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit,...	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ...	Class III	Tripath Imaging, Inc.
Mar 22, 2012	PrepStain Installation Kit (PreCoat), Catalog/Model # 490528	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ...	Class III	Tripath Imaging, Inc.
Mar 22, 2012	Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ...	Class III	Tripath Imaging, Inc.
Mar 19, 2012	Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, Wes...	Ten units of Model EMV+ Devices were shipped out in error before the verification and validation ...	Class III	Impact Instrumentation, Inc.
Mar 8, 2012	BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Ind...	Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expirati...	Class III	Helix Medical LLC
Mar 5, 2012	BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collecti...	BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Ligh...	Class III	Becton Dickinson & Company
Feb 28, 2012	Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diag...	The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain...	Class III	Critical Diagnostics
Feb 24, 2012	Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage...	During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6...	Class III	Roche Molecular Systems, Inc.
Feb 15, 2012	Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic ...	A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates li...	Class III	Medtest Holdings, Inc.
Dec 15, 2011	Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number ...	The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron...	Class III	Beckman Coulter Inc.
Nov 15, 2011	Sunquest Laboratory : intended for use by professionals working in a clini...	Online calculations may not be performed as expected or may yield results that are different than...	Class III	Sunquest Information Systems, Inc.
Oct 19, 2011	Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit compris...	Linear performance information in product insert does not match that listed in the approved prema...	Class III	Medtest Holdings, Inc.
Oct 11, 2011	Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for t...	A recall was initiated because Beckman Coulter has identified a negative bias in test results whe...	Class III	Beckman Coulter Inc.
Aug 12, 2011	Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage...	In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the access...	Class III	Sunquest Information Systems, Inc.
Apr 28, 2011	Sunquest Laboratory SMART & Sunquest Laboratory SMART Select	In Online Entry (OEx) there are two scenarios where a Test result from one container may file to ...	Class III	Sunquest Information Systems, Inc.
Mar 24, 2011	Boule Con-Diff Hematology Control For in vitro diagnostic use as a control...	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc...	Class III	Clinical Diagnostic Solutions
Mar 24, 2011	Boule Con-Diff Hematology Control For in vitro diagnostic use as a control...	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc...	Class III	Clinical Diagnostic Solutions
Mar 24, 2011	Boule Con-Diff Hematology Control For in vitro diagnostic use as a control...	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc...	Class III	Clinical Diagnostic Solutions
Mar 4, 2011	Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated s...	Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (...	Class III	Baxter Healthcare Corp.
Mar 4, 2011	Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syr...	Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (...	Class III	Baxter Healthcare Corp.
Dec 31, 2010	ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Ki...	The impacted product was not intended for commercial distribution to end users.	Class III	Kimberly-Clark Corporation
Nov 22, 2010	The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level ...	Incorrect control range in product labeling	Class III	Medtest Holdings, Inc.
Aug 18, 2010	G7 HPLC. Used as an aid in the detection and presumptive identification of...	The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performan...	Class III	Tosoh Bioscience Inc
Aug 4, 2010	Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a cont...	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Pr...	Class III	Clinical Diagnostic Solutions
Aug 4, 2010	Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as ...	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Pr...	Class III	Clinical Diagnostic Solutions
Jul 21, 2009	Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(H...	Individual vials of calibrator and standard were mislabeled; specifically the units on the vial l...	Class III	Medtest Holdings, Inc.
Apr 17, 2009	Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. ...	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.	Class III	Spinal Elements, 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.