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

Date	Product	Reason	Class	Firm
Nov 19, 2014	VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho C...	Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ...	Class II	Ortho-Clinical Diagnostics
Nov 7, 2014	adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used wit...	Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Sou...	Class II	Ion Beam Applications S.A.
Sep 29, 2014	VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis...	Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod...	Class III	Ortho-Clinical Diagnostics
Sep 8, 2014	VITROS 5600 Integrated System, System Product Code 6802413. For use in the...	Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the...	Class II	Ortho-Clinical Diagnostics
Sep 8, 2014	VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Pro...	Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the...	Class II	Ortho-Clinical Diagnostics
Aug 28, 2014	Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnos...	Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calib...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 18, 2014	Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in v...	Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 6, 2014	ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems...	The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin...	Class II	Siemens Healthcare Diagnostics
Jul 22, 2014	ICT Serum Calibrator REF 146-03. For use in the calibration of the serum ...	ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient ...	Class II	Abbott Laboratories
Jul 15, 2014	VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and...	Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Cali...	Class II	Ortho-Clinical Diagnostics
Jun 25, 2014	McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for comple...	McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to es...	Class II	Mckesson Information Solutions LLC
Jun 23, 2014	SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test ...	Complaints of failed calibration.	Class II	Siemens Healthcare Diagnostics, Inc
Jun 23, 2014	SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test ...	Complaints of failed calibration.	Class II	Siemens Healthcare Diagnostics, Inc
May 30, 2014	Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoa...	Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family o...	Class III	Alere San Diego, Inc.
May 9, 2014	Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da V...	Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to ove...	Class II	Intuitive Surgical, Inc.
Apr 30, 2014	HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL a...	HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calib...	Class II	Abbott Laboratories
Apr 22, 2014	illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 ...	Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a res...	Class II	Meridian Bioscience Inc
Apr 16, 2014	Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use wi...	Integra LifeSciences has identified through a small number of complaints that some lot numbers of...	Class II	Integra LifeSciences Corp.
Apr 8, 2014	Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) ...	There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Cal...	Class II	Bio-Rad Laboratories, Inc.
Apr 1, 2014	550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliv...	Table may lose calibration during patient treatment, which may cause the possibility of mistreatm...	Class II	Siemens Medical Solutions USA, Inc
Feb 20, 2014	VITROS TT4 Calibrator For the quantitative measurement of total thyroxine ...	Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.	Class II	Ortho-Clinical Diagnostics
Feb 18, 2014	Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; I...	Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified thro...	Class III	Lin-Zhi International Inc
Jan 29, 2014	VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalo...	Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Prod...	Class II	Ortho-Clinical Diagnostics
Jan 20, 2014	ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX...	HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running t...	Class II	Horiba Instruments, Inc dba Horiba Medical
Jan 15, 2014	VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATAL...	Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin...	Class III	Ortho-Clinical Diagnostics
Jan 9, 2014	VITROS Chemistry Products White Reference Slides, White Correction Factor Sli...	An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (fi...	Class II	Ortho-Clinical Diagnostics
Jan 6, 2014	Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An...	Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) a...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 25, 2013	Agility. Version 3.1 of the Integrity interface and control software for the...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user in...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	Integrity. Version 1.1 of the Integrity interface and control software for t...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	Desktop Pro TM linear accelerator control software intended to assist a licen...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	Agility. Version 3.0 of the Integrity interface and control software for the...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 15, 2013	BrainLAB's VectorVision spine is intended for use as an intraoperative image-...	Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with sp...	Class II	Brainlab AG
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.
Oct 16, 2013	Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog...	Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot ...	Class II	Microgenics Corp
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
Sep 17, 2013	Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI ...	Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shi...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 30, 2013	GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is inte...	GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device...	Class II	GE Healthcare, LLC
Jul 30, 2013	ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/US...	Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up t...	Class II	Siemens Healthcare Diagnostics
Jul 25, 2013	ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro...	Calibration failures and/or significant negative shifts in quality control (QC) and patient results.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 25, 2013	ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vi...	Calibration failures and/or significant negative shifts in quality control (QC) and patient results.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 25, 2013	ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro d...	Calibration failures and/or significant negative shifts in quality control (QC) and patient results.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 25, 2013	ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In v...	Calibration failures and/or significant negative shifts in quality control (QC) and patient results.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 15, 2013	Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy Syste...	Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). Fo...	Class II	China Daheng Group Inc.
Jun 10, 2013	pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, O...	RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner sol...	Class II	Radiometer America Inc
May 29, 2013	Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTI...	The information regarding the FILM Mode calibration may have been considered difficult to interpr...	Class II	Siemens Medical Solutions USA, Inc
May 28, 2013	SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) ...	Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with erro...	Class II	Beckman Coulter Inc.
Apr 24, 2013	embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilato...	Calibration error for Embla Embletta Gold units calibrated through service center between June 15...	Class II	Embla System Llc
Apr 3, 2013	VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho...	Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 de...	Class III	Ortho-Clinical Diagnostics
Mar 28, 2013	Integrity 1.1. Integrity is the interface and control software for the Ele...	The problem is that the "static tolerances" from the calibration files (loaded database) are used...	Class II	Elekta, 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.