Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 ClearCanvas RIS/PACS A software defect negatively affects the quality of images taken during diagnostic imaging (mammo... Class II Synaptive Medical Inc
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 25, 2020 Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrate... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 25, 2020 Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 25, 2020 Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Tra... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 25, 2020 Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Tri... An issue within production process used to package trial kits let to the inclusion of the incorr... Class II Kerr/Pentron, DBA Kerr Corporation and Pentron ...
Feb 25, 2020 Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper A... Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may ... Class II Biomet, Inc.
Feb 25, 2020 Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Tran... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 24, 2020 Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool... Distributed without an approved 510(k) Class II Butterfly Network, Inc.
Feb 24, 2020 Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volu... Distributed without an approved 510(k) Class II Butterfly Network, Inc.
Feb 24, 2020 LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System... The firm is providing validated cleaning and disinfection instructions in their revised operating... Class II LivaNova USA Inc.
Feb 21, 2020 AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box)... An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The c... Class II Qiagen Sciences LLC
Feb 21, 2020 R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124;... Incorrect expiration date on introduction cannula packaging. Class II Epimed International
Feb 21, 2020 R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496;... Incorrect expiration date on introduction cannula packaging. Class II Epimed International
Feb 20, 2020 RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment ... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment ... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor mo... Reports have been received about the transcutaneous monitoring system display flickering or monit... Class II Radiometer Medical ApS
Feb 20, 2020 Expression MR400 MRI Patient Monitoring System Model Number: 866185 Softwa... Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incor... Class II Philips North America, LLC
Feb 20, 2020 Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with... Class II Maquet Cardiovascular Us Sales, Llc
Feb 20, 2020 RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone softw... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone soft... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone softw... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 19, 2020 TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.... Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to ... Class II Haemonetics Corporation
Feb 18, 2020 KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 18, 2020 QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that ... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 18, 2020 PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versi... Potential safety issue with the dose monitoring system safety interlocks which could result in a ... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console S... Potential safety issue with the dose monitoring system safety interlocks which could result in a ... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Us... The firm received reports of a number of broken latches on the floorsitter. Class II James Leckey Design Ltd
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic ... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 18, 2020 QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verificatio... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #585... Potential safety issue with the dose monitoring system safety interlocks which could result in a ... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2020 Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Us... The control target and range value for Sodium using the ISE indirect method has been assigned inc... Class II Randox Laboratories Ltd.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that ... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, ME... Potential safety issue with the dose monitoring system safety interlocks which could result in a ... Class II Siemens Medical Solutions USA, Inc
Feb 17, 2020 AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode... hearing performance degradation due to body-fluid entering the device. Class II Advanced Bionics, LLC
Feb 17, 2020 AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usa... hearing performance degradation due to body-fluid entering the device. Class II Advanced Bionics, LLC
Feb 17, 2020 Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Prod... A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. Class II Biomet, Inc.
Feb 17, 2020 iChemVELOCITY Strips, Catalog 800-7212 The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iCh... Class II Beckman Coulter, 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.