Browse Device Recalls

1,062 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,062 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 1,062 FDA device recalls in OH.

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DateProductReasonClassFirm
Feb 4, 2019 US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock... Potential esophageal laceration during a patient procedure Class II US Endoscopy Group Inc
Jan 22, 2019 COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 4, 2019 SWIN 2017 database, Model YSW4000 Potential for out of range microbial results Class II Remel Inc.
Dec 26, 2018 ATLAS Loading Car The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when t... Class II Steris Corporation
Dec 20, 2018 AMSCO 3000 Series Washer/Disinfector Model # 3052 The software in the systems may not process the cycle originally intended. This could result in d... Class II Steris Corporation
Dec 20, 2018 AMSCO 5000 Series Washer/Disinfector Model # 5052 The software in the systems may not process the cycle originally intended. This could result in d... Class II Steris Corporation
Dec 19, 2018 Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagn... A software update is being issued to correct multiple issues identified in the previous software ... Class II Philips Medical Systems (Cleveland) Inc
Dec 19, 2018 Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: ... Evidence supports that when customers performed a fuse replacement as part of a March 2017 field ... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Dec 17, 2018 PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PR... An enzyme reagent included in the kit is not maintaining stability through claimed product expira... Class II Meridian Bioscience Inc
Dec 7, 2018 PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: ... Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially caus... Class II Ethicon Endo-Surgery Inc
Dec 7, 2018 PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: Th... Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially caus... Class II Ethicon Endo-Surgery Inc
Nov 30, 2018 AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for t... Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh A... Class II Tosoh Bioscience Inc
Nov 30, 2018 ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOS... Class II Tosoh Bioscience Inc
Nov 30, 2018 ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY f... Class II Tosoh Bioscience Inc
Nov 30, 2018 ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY f... Class II Tosoh Bioscience Inc
Nov 30, 2018 AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the qu... Class II Tosoh Bioscience Inc
Nov 30, 2018 ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO... Class II Tosoh Bioscience Inc
Nov 16, 2018 Presource Kit Total Joint Pack containing a double-wrapped basin component. ... The double wrapping of this custom kit basin set is not supported by the current sterility assura... Class II Cardinal Health Inc.
Nov 16, 2018 Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P ... Invacare has identified via customer complaints, the potential for the mounting bolt connecting t... Class II Invacare Corporation
Oct 18, 2018 Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomograph... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomograph... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray sys... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomogra... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray syst... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 5, 2018 AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Produ... Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotati... Class II Tosoh Bioscience Inc
Oct 5, 2018 AIA-900 Analyzer, Product code 022930, 022930R Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor o... Class II Tosoh Bioscience Inc
Oct 5, 2018 Hemoglobin A1c Control, Part no. 220232 for use as quality control material t... Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the... Class III Tosoh Bioscience Inc
Sep 28, 2018 Tosoh AIA-900 immunoassay Analyzer A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to... Class II Tosoh Bioscience 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
Sep 28, 2018 AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AI... Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers th... Class II Tosoh Bioscience Inc
Sep 28, 2018 AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-... Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers th... Class II Tosoh Bioscience Inc
Sep 4, 2018 Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Rese... Potential for membrane (control panel) switch errors leading to an inability of the device to cha... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Sep 4, 2018 Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usa... Software Correction: Software errors that may result in incorrect 4D CT images, PET images with S... Class II Philips Medical Systems (Cleveland) Inc
Aug 23, 2018 AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated... The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These label... Class II Tosoh Bioscience Inc
Aug 21, 2018 ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catal... ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 Class II Coltene Whaledent Inc
Jul 26, 2018 AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Syst... There is the potential for a scenario where a punctured cup of sterilant expires while the system... Class II Steris Corporation
Jul 13, 2018 G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use... Analyzers were distributed with software which lacks a 510K Class II Tosoh Bioscience Inc
Jul 3, 2018 Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems in... Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... Class II Philips Medical Systems (Cleveland) Inc
Jul 3, 2018 Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems i... Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... Class II Philips Medical Systems (Cleveland) Inc
Jul 3, 2018 Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray system... Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... Class II Philips Medical Systems (Cleveland) Inc
Jun 29, 2018 Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indic... The firm received a complaint where, during patient positioning, the technologist was adjusting t... Class II Hitachi Medical Systems America Inc
Jun 29, 2018 Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B P... Packages labeled as containing 110mm rods may contain 100mm rods. Class II Back 2 Basics Direct LLC
Jun 18, 2018 CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L ... A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement ... Class I Compass Health Brands (Corporate Office)
Jun 18, 2018 Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging d... The stainless steel belt which runs the length of the table underneath the tabletop is exposed wh... Class II Hitachi Medical Systems America Inc
Jun 8, 2018 Zimmer Dermatone AN, Model No. 88710100 Devices may have a loose control bar, which could compromise the ability to control the thickness... Class II Zimmer Surgical Inc
Jun 6, 2018 G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 ... HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Cu... Class II Tosoh Bioscience 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.