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
Jun 22, 2016	Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple ...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For ...	The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the a...	Class III	Ortho-Clinical Diagnostics
Jun 22, 2016	Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 21, 2016	Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF ...	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula...	Class III	MicroPort Orthopedics Inc.
Jun 21, 2016	Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26...	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula...	Class III	MicroPort Orthopedics Inc.
Jun 21, 2016	Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF P...	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula...	Class III	MicroPort Orthopedics Inc.
Jun 21, 2016	Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, R...	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula...	Class III	MicroPort Orthopedics Inc.
Jun 21, 2016	Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF...	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula...	Class III	MicroPort Orthopedics Inc.
Jun 21, 2016	Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36...	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula...	Class III	MicroPort Orthopedics Inc.
Jun 21, 2016	Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF ...	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula...	Class III	MicroPort Orthopedics Inc.
Jun 7, 2016	Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as o...	Instructions For Use had incorrect lot number and calibrator values	Class III	Tosoh Bioscience, Inc.
Jun 1, 2016	PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix ...	BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following...	Class III	Becton Dickinson & Co.
Jun 1, 2016	PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoeni...	BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the fol...	Class III	Becton Dickinson & Co.
May 24, 2016	VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used ...	Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VI...	Class III	Ortho-Clinical Diagnostics
May 17, 2016	cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Inf...	Kit labeled with the incorrect expiration date.	Class III	Roche Molecular Systems, Inc.
May 16, 2016	enGen Laboratory Automation System, Product Code engen, Software Versions enG...	If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numeri...	Class III	Ortho-Clinical Diagnostics
May 9, 2016	VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784,...	Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products...	Class III	ORTHO-CLINICAL DIAGNOSTICS
May 6, 2016	Ariol is an automated scanning microscope and image analysis system. It is in...	An issue during the manufacturing process caused systems to have an improperly activated Windows ...	Class III	Leica Biosystems Richmond Inc.
May 5, 2016	The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Am...	Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the...	Class III	Siemens Healthcare Diagnostics, Inc.
May 5, 2016	The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration...	Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the...	Class III	Siemens Healthcare Diagnostics, Inc.
May 2, 2016	CytoVision Image Analysis and Capture System, an automated cell-locating devi...	Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was asso...	Class III	Leica Biosystems Richmond Inc.
Apr 25, 2016	Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-8...	Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips w...	Class III	GSK Consumer Healthcare
Apr 19, 2016	The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunctio...	There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will pr...	Class III	Ortho-Clinical Diagnostics
Apr 15, 2016	VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated qu...	Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.	Class III	Biomerieux France Chemin De L'Or
Apr 14, 2016	CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, w...	During a recent Ohio site inspection by the FDA it was discovered that warning statements needed ...	Class III	Affymetrix Inc
Mar 31, 2016	Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog...	Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ...	Class III	Biocare Medical, LLC
Mar 30, 2016	ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710,...	The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two ina...	Class III	Siemens Healthcare Diagnostics, Inc.
Mar 23, 2016	Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gel...	Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016....	Class III	Acumedia Manufacturers, Inc.
Mar 18, 2016	BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro ...	The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect stor...	Class III	Becton, Dickinson and Company, BD Biosciences
Mar 17, 2016	Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cle...	Foreign material in container	Class III	Cygnus Medical
Mar 11, 2016	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Pa...	There is a potential problem with the cuvette where failure of the cuvette would cause an error m...	Class III	Datascope Corporation
Mar 11, 2016	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Numb...	There is a potential problem with the cuvette where failure of the cuvette would cause an error m...	Class III	Datascope Corporation
Mar 11, 2016	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Specia...	There is a potential problem with the cuvette where failure of the cuvette would cause an error m...	Class III	Datascope Corporation
Feb 29, 2016	Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffe...	Lot was not functioning properly and not exhibiting the correct physical properties.	Class III	AMS Diagnostics, LLC
Feb 16, 2016	Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For us...	Multiple complaints were received from customers indicating that they ordered product 8335(Type 3...	Class III	Richard-Allan Scientific Company
Feb 4, 2016	Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascu...	Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tub...	Class III	Medtronic Perfusion Systems
Feb 2, 2016	Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for ...	The firm discovered that the incorrect lot number was engraved on the product.	Class III	Volk Optical Inc
Jan 25, 2016	BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in ...	Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expi...	Class III	Becton, Dickinson and Company, BD Biosciences
Jan 19, 2016	CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Pe...	The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HI...	Class III	Sorin Group USA, Inc.
Jan 18, 2016	CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Descript...	Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recomm...	Class III	Lab Vision Corporation
Jan 15, 2016	OraQuick HCV Visual Reference Panel Intended to assist new operation in b...	OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Ant...	Class III	OraSure Technologies, Inc.
Jan 4, 2016	REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapte...	Report by a customer of an open package seal.	Class III	C.R. Bard, Inc.
Dec 14, 2015	FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.	Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting function...	Class III	Becton, Dickinson and Company, BD Biosciences
Dec 11, 2015	CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows:...	Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor ...	Class III	Terumo Cardiovascular Systems Corporation
Nov 17, 2015	ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in...	The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working pr...	Class III	Collagen Matrix Inc
Nov 16, 2015	DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech 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.