Browse Device Recalls

2,115 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,115 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 2,115 FDA device recalls in N/A.

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DateProductReasonClassFirm
Oct 16, 2014 Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility T... The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Class III Biomerieux
Oct 6, 2014 Synthes Inflation System (03.804.4135) Product Usage: Inflation system i... Additional instructions for use due to inability to raise the pressure above 10 atm during inflat... Class II PEROUSE MEDICAL
Oct 6, 2014 Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device i... Additional instructions for use due to inability to raise the pressure above 10 atm during inflat... Class II PEROUSE MEDICAL
Sep 25, 2014 COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear ... Error in the software. A deviation between reconstructed and planned dose distribution may not b... Class II Iba Dosimetry Gmbh
Sep 17, 2014 nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic... An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... Class II NordicNeuroLab AS
Sep 12, 2014 nordicICE 2.3.14 Image processing software package used by trained profess... An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... Class II NordicNeuroLab AS
Sep 11, 2014 Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ... Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... Class II The Binding Site Group, Ltd.
Sep 11, 2014 Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II... Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... Class II The Binding Site Group, Ltd.
Sep 11, 2014 ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.... 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may ex... Class II Abbott Ireland Diagnostics Division
Sep 11, 2014 Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"600... Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... Class II The Binding Site Group, Ltd.
Sep 11, 2014 Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Produ... Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... Class II The Binding Site Group, Ltd.
Sep 11, 2014 MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is inte... Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... Class II The Binding Site Group, Ltd.
Sep 11, 2014 Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 L... Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... Class II The Binding Site Group, Ltd.
Sep 11, 2014 Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit ... Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... Class II The Binding Site Group, Ltd.
Sep 1, 2014 Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Inte... The firm received complaints regarding multiple mattresses were showing failures resulting in pre... Class II Arjo Hospital Equipment AB
Aug 28, 2014 TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Po... Motion Concepts identified that there is a possibility of knee support failure occurring through ... Class II Motion Concepts
Aug 11, 2014 ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. ... Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing tha... Class III ELITech Clinical Systems SAS
Aug 6, 2014 VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitati... VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower... Class II ORTHO-CLINICAL DIAGNOSTICS
Aug 6, 2014 MobileDiagnost wDR motorized portable diagnostic X-ray systems. Reports of unexpected movement. Class II Sedecal S.A.
Aug 3, 2014 Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). ... suction canister lids may have occluded ports. Class II EMG Technology Co., Ltd.
Jul 28, 2014 Minstrel (with scale) Product Usage: is a mobile passive hoist. It is inte... ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. The... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jul 16, 2014 VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot ... Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 1... Class II ORTHO-CLINICAL DIAGNOSTICS
Jul 5, 2014 VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medica... Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, t... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Jun 25, 2014 The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a pol... A potential splitting of the surface treatment of the thread ends on certain sutures has recently... Class II Peters Surgical
Jun 25, 2014 The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are compos... A potential splitting of the surface treatment of the thread ends on certain sutures has recently... Class II Peters Surgical
Jun 24, 2014 ExacTrac is intended to be used to place patients at an accurately defined po... When using multiple isocenters (radiation treatment targets) within a single plan, in certain wor... Class II Brainlab AG
Jun 10, 2014 Tenor is a mobile passive lift, intended to be used on horizontal surfaces fo... ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke durin... Class II ARJOHUNTLEIGH POLSKA SP. ZO.O.
May 21, 2014 Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intrao... Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intra... Class II Brainlab AG
May 9, 2014 ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton ... Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitor... Class II VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
Apr 25, 2014 RayStation software version 4.0.3.4 RayStation is a software system design... This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT h... Class II RAYSEARCH LABORATORIES AB
Apr 15, 2014 Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP... The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is like... Class I Fisher & Paykel Healthcare, Ltd.
Mar 27, 2014 Proteus 235 Proton Therapy System for cancer treatment. While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low... Class II Ion Beam Applications S.A.
Mar 10, 2014 SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installe... The System may go into a controlled failed state if a series of parameters on the user interface ... Class I Del Mar Reynolds Medical, Ltd.
Mar 6, 2014 API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (... bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... Class II BioMerieux SA
Mar 6, 2014 FB Reagent (REF 70562). FB reagent is an additional test used for revealin... bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... Class II BioMerieux SA
Mar 6, 2014 API Listeria (REF 10300). ZYM B reagent is used and included inside of API... bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... Class II BioMerieux SA
Mar 6, 2014 ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to... bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... Class II BioMerieux SA
Mar 5, 2014 Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. ... The outer package label contained the incorrect length of the device. There is a label on the out... Class II Pega Medical Inc.
Feb 17, 2014 TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkst... If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the ... Class III Technidata S.A.
Feb 14, 2014 RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alon... RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software d... Class II RAYSEARCH LABORATORIES AB
Feb 7, 2014 Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid ... The Male Components in this lot are made of material with lower strength than manufacturing speci... Class II Pega Medical Inc.
Feb 6, 2014 RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 ... Potential for dose errors due to software program errors. Class II RAYSEARCH LABORATORIES AB
Feb 6, 2014 RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alo... RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calcu... Class II RAYSEARCH LABORATORIES AB
Feb 3, 2014 Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured b... Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. Class II Carl Zeiss Meditec AG
Dec 4, 2013 Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, m... Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculatio... Class II Ion Beam Applications S.A.
Nov 29, 2013 steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in process... Error copying information to the clinical file and to the report when two 3D models are opened si... Class II EOS Imaging
Nov 18, 2013 Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative imag... The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows ... Class II Brainlab AG
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
Oct 14, 2013 VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measure... Product is not approved or authorized for distribution in the US. Class II BioMerieux SA
Sep 27, 2013 Breeze C Scooter is a motorized electric scooter for elderly people. Brand ... Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it... Class II S.A.E. AFIKIM

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.