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.

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Date	Product	Reason	Class	Firm
Jul 29, 2019	OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565	There is a potential that users may experience difficulty validating the calibration of the kit. ...	Class II	The Binding Site Group, Ltd.
Jul 12, 2019	This is an in vitro diagnostic product intended for use as a calibration seru...	Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for AL...	Class III	Randox Laboratories Ltd.
Jul 8, 2019	VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che...	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 5600 Integrated System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 350 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 4600 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 4600 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 250AT Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 5,1 FS Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che...	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 5,1 FS Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 250 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 250 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 5600 Integrated System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 2, 2019	The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay...	The firm conducted internal investigations that confirmed customer complaints of quality control ...	Class II	Roche Diagnostics Operations, Inc.
Jul 1, 2019	Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 1163456...	Calibration; it has been determined that the capnographs may have been calibrated during manufact...	Class II	CareFusion 303, Inc.
Jun 17, 2019	da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601...	One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. Th...	Class II	Intuitive Surgical, Inc.
Jun 7, 2019	Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Re...	The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a...	Class III	Polymer Technology Systems, Inc.
Jun 7, 2019	PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: ...	The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a...	Class III	Polymer Technology Systems, Inc.
Jun 3, 2019	The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies...	Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and qua...	Class II	Roche Diagnostics Corporation
May 24, 2019	ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators ar...	Presence of a time dependent, stability drift in patient and control results returned from ARCHIT...	Class III	Abbott Laboratories
May 23, 2019	Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software v...	During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscr...	Class II	Obalon Therapeutics Inc
May 22, 2019	"HEMOGLOBIN A1c CALIBRATORS * REF 4P52-01 * 307261/R03 * S4P5X0 * FOR...	Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The ma...	Class II	Abbott Laboratories
Apr 29, 2019	DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraor...	The sensor's look up calibration files were incorrectly programmed during manufacturing, which ca...	Class II	KaVo Dental Technologies LLC
Apr 9, 2019	ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calib...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Cali...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators ...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibr...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Ca...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 3, 2019	BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Ve...	Background calibration has the potential to cause false positive or false negative test results. ...	Class II	Becton Dickinson & Co.
Apr 3, 2019	BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System ...	Background calibration has the potential to cause false positive or false negative test results. ...	Class II	Becton Dickinson & Co.
Mar 18, 2019	Albumin BCP Product Usage: ALBP is an in vitro test used for the quantit...	The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due ...	Class II	Roche Diagnostics Corporation
Mar 8, 2019	ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the ...	Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.	Class II	ulrich medical USA Inc
Mar 6, 2019	TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877	The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss...	Class II	Acclarent, Inc.
Mar 6, 2019	TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891	The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss...	Class II	Acclarent, Inc.
Mar 6, 2019	TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884	The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss...	Class II	Acclarent, Inc.
Feb 19, 2019	Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Prot...	Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits	Class II	The Binding Site Group, Ltd.
Dec 20, 2018	Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30...	Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) ...	Class II	Abbott Gmbh & Co. KG
Dec 6, 2018	I-View¿ Contrast Enhanced Digital Mammography, ASY-08109	Calibration issue not possible to visualize contrast uptake in the subtracted mammography images	Class II	Hologic, Inc.
Dec 4, 2018	Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6	Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order t...	Class III	Stryker Instruments Div. of Stryker Corporation
Dec 3, 2018	Fructosamine Control 1, FR2994 This product is intended for in vitro use ...	The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ...	Class II	Randox Laboratories Ltd.
Dec 3, 2018	Fructosamine Calibrator, FR2993 This product is intended for in vitro use ...	The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ...	Class II	Randox Laboratories Ltd.
Dec 3, 2018	Fructosamine Control 3, FR2996 This product is intended for in vitro use ...	The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ...	Class II	Randox Laboratories Ltd.
Nov 29, 2018	Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration...	A stability issue in the calibrators may cause calibration failures or atypical Quality Control r...	Class II	Ortho Clinical Diagnostics Inc
Nov 6, 2018	Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists...	Firm is offering advice to customers experiencing challenges when validating the calibration curv...	Class II	The Binding Site Group, Ltd.
Oct 17, 2018	Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Elec...	An intermittent failure which causes a blender initialization fault upon start-up or during an EP...	Class II	Terumo Cardiovascular Systems Corporation
Oct 16, 2018	Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intend...	Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v....	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 16, 2018	Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intende...	Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v....	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 28, 2018	AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AI...	There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as...	Class II	Tosoh Bioscience Inc
Aug 31, 2018	Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is ...	the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and ma...	Class II	Accuray Incorporated

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.