Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

530 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 530 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 530 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 15, 2013 The GemStar Pump is a small and lightweight, single channel infusion device d... The proximal and distal pressure sensor calibration can drift resulting in the pump failing the P... Class I Hospira Inc.
Mar 15, 2013 The GemStar Pump is a small and lightweight, single channel infusion device d... The proximal and distal pressure sensor calibration can drift resulting in the pump failing the P... Class I Hospira Inc.
Dec 28, 2012 Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reag... Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) ... Class II Beckman Coulter Inc.
Dec 20, 2012 Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The... Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable... Class III Siemens Healthcare Diagnostics, Inc.
Nov 28, 2012 Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry an... Due to a software data storage limitation which only occurs under certain conditions, measurement... Class II Beckman Coulter Inc.
Nov 28, 2012 Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in th... Calibration curve activity has increased over time in the kit lots listed. Class II The Binding Site Group, Ltd.
Nov 1, 2012 VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B sur... Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an ina... Class III Ortho-Clinical Diagnostics
Oct 22, 2012 Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88... Out of range (increased) HDL Cholesterol results. Class III Alere San Diego, Inc.
Oct 10, 2012 Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Dia... Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibratio... Class II Alfa Wassermann, Inc.
Oct 10, 2012 Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP C... Correlation slope bias and accuracy shift Class III Siemens Healthcare Diagnostics, Inc.
Sep 14, 2012 ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot N... This recall was initiated because some customers were experiencing an alarm during Creatinine cal... Class III Horiba Instruments, Inc dba Horiba Medical
Sep 11, 2012 Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) ... BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the... Class II Siemens Healthcare Diagnostics, Inc
Aug 9, 2012 Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridg... Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibratio... Class II Siemens Healthcare Diagnostics, Inc.
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 MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. ... Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and e... Class II Sekisui Diagnostics Llc
May 11, 2012 Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured... Class II Philips Healthcare Inc.
Feb 23, 2012 Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VI... Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, ... Class II Tosoh Bioscience Inc
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part:... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: Th... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PL... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira 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.
Oct 6, 2011 Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS ... Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... Class II Orthosoft, Inc. dba Zimmer CAS
Sep 6, 2011 Animas Vibe Insulin Infusion Pump. This product is indicated for continuou... Calibration factors in the pump overwritten during a programming step. The force sensor could sen... Class II Animas Corporation
May 16, 2011 GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscop... GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes dur... Class II GE Healthcare, LLC
Sep 22, 2010 ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600... Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because i... Class II Beckman Coulter Inc.
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.

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.