Browse Device Recalls

2,055 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,055 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 2,055 FDA device recalls in N/A.

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DateProductReasonClassFirm
Jun 21, 2013 MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or e... Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue asso... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Jun 20, 2013 TDHistology/Cytology Classification name: Calculator/data processing modul... A recall was initiated by Technidata because use of symbols (less than or equal to or greater tha... Class III Technidata S.A.
Jun 7, 2013 Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workst... Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer... Class II Del Mar Reynolds Medical, Ltd.
May 23, 2013 Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt ... Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Sw... Class II Etac Supply Center Ab
May 14, 2013 Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liqui... It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks li... Class II Penlon, Ltd.
May 10, 2013 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 ... MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to ... Class II ErgoSafe Product LLC dba Prism Medical Services
Apr 22, 2013 Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereota... Software Error: The effect of setup on overall navigation accuracy could potentially intensify sm... Class I Brainlab AG
Apr 22, 2013 Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). ... Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power ... Class II Fisher & Paykel Healthcare, Ltd.
Apr 17, 2013 The Constellation Vision System Pneumatic Handpiece. Indicated for both an... Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, prod... Class II Alcon Grieshaber AG
Apr 17, 2013 VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instrum... Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefor... Class II BioMerieux SA
Apr 9, 2013 Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103... Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the ... Class II Alpine Biomed Aps
Mar 20, 2013 REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found i... Investigation of complaints found excessive use of the instrument could result in cracking on the... Class II Biomet U.K., Ltd.
Feb 15, 2013 Molift Smart 150 The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user. Class II Moller Vital
Feb 15, 2013 Molift Smart 150 The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user. Class II Moller Vital
Feb 15, 2013 RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0... Under some circumstances, imported CT, MR and PET images are offset from their true positions by ... Class II RAYSEARCH LABORATORIES AB
Jan 15, 2013 Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Worksta... A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may caus... Class I Del Mar Reynolds Medical, Ltd.
Dec 21, 2012 nordicBrainEX Product Usage: nordicBrainEx is an image processing softwar... There is an error related to the relative geometry between fiber tracts in a fiber group and imag... Class II NordicNeuroLab AS
Dec 18, 2012 Surgical microscope The device is used to improve the visibility of object... The brake in the Z axis and/or brakes in the AB and C axes failed during installation. Class II Leica Microsystems (Schweiz) Ag
Dec 18, 2012 Surgical microscope The device is used to improve the visibility of object... The brake in the Z axis and/or brakes in the AB and C axes failed during installation. Class II Leica Microsystems (Schweiz) Ag
Dec 5, 2012 Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product ... Canon Inc. had received 17 claims from our foreign sales companies between October to November ... Class II Canon Inc.
Nov 19, 2012 Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing ... FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes... Class I Fisher & Paykel Healthcare, Ltd.
Nov 7, 2012 Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Trea... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.
Nov 7, 2012 Analyzing system consists of a small and portable analyzer and plastic microc... Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made fro... Class III HemoCue AB
Nov 7, 2012 Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.
Nov 7, 2012 Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hai... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.
Nov 7, 2012 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hyd... Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report... Class II IDS (Immunodiagnostic Systems Ltd.)
Nov 5, 2012 SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane... A manufacturing defect was observed for the membrane changer insert that does not allow electroly... Class II Sentec AG
Nov 5, 2012 SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign ... A manufacturing defect was observed for the membrane changer insert that does not allow electroly... Class II Sentec AG
Nov 1, 2012 Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I ... APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect bar... Class II Abbott Point of Care Canada Limited
Oct 18, 2012 NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz D... The four screws that secure the patient table top to the carrier pulled out and caused the table ... Class II Philips And Neusoft Medical Systems Co., Ltd.
Sep 26, 2012 DeGotzen XRay unit XGenus Dental X-ray unit. It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certi... Class II DeGotzen
Sep 13, 2012 HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to... Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions tha... Class I Heartsine Technologies, Limited
Aug 10, 2012 IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Pac... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box conta... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Bo... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 MyRay RXDC dental unit x-ray unit The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30... Class II CEFLA DENTAL GROUP
Aug 10, 2012 IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboa... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number ... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Ca... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Bo... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Jul 27, 2012 Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate che... A drafting error during an unrelated design change has led to 4 misleading dimensions on the draw... Class II Biomet U.K., Ltd.
May 9, 2012 Brand name: RayStation. Generic name: Treatment Planning System. Software ... The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, R... Class II RAYSEARCH LABORATORIES AB
Jan 10, 2012 Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automate... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog #... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automate... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Us... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: aut... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 5, 2012 Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is inte... Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant rep... Class II Cook Ireland Ltd.
Oct 10, 2011 SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manu... This notice concerns behavior of the SharePlan that may be unexpected and not clearly described i... Class II RAYSEARCH LABORATORIES AB
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

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.