Browse Device Recalls

2,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,087 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 2,087 FDA device recalls in 2026.

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DateProductReasonClassFirm
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Numb... Potential for arterial sheath tip separation or partial tip separation during use. Class I Boston Scientific Corporation
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material... Potential for arterial sheath tip separation or partial tip separation during use. Class I Boston Scientific Corporation
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114... Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) ... Class II Henry Schein Inc.
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY ... Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 8, 2026 TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to m... Class II Tobii Dynavox Llc
Jul 8, 2026 Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline... Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... Class II Medline Industries, LP
Jul 8, 2026 Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experien... Class II Fort Defiance Industries, LLC
Jul 8, 2026 Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline ... Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... Class II Medline Industries, LP
Jul 8, 2026 Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SK... Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... Class II Medline Industries, LP
Jul 8, 2026 Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Ki... Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... Class II Medline Industries, LP
Jul 8, 2026 TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to m... Class II Tobii Dynavox Llc
Jul 7, 2026 Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containin... Devices could potentially contain an occluded or partially occluded Guedel Airway tip. Class II INTEGRATED MEDCRAFT LLC
Jul 7, 2026 FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011... Devices could potentially contain an occluded or partially occluded Guedel Airway tip. Class II INTEGRATED MEDCRAFT LLC
Jul 7, 2026 Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powere... Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss ... Class II Olympus Corporation of the Americas
Jul 6, 2026 Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US Transfemoral catheter, positing arm may detached due to weld issue. Class II PI CARDIA LTD
Jul 6, 2026 Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704... Urostomy Pouches may leak from cap during use. Class II ConvaTec, Inc
Jul 6, 2026 Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, R... The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains ... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 6, 2026 Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride I... Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance... Class I Spectra Medical Devices, Llc
Jul 6, 2026 Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely d... Class II Siemens Healthcare Diagnostics, Inc.
Jul 2, 2026 Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm ... Potential for false negative patient results. Class II DRG International, Inc.
Jul 2, 2026 OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17... Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone gra... Class II IsoTis OrthoBiologics, Inc.
Jul 1, 2026 Cardiac Workstation 7000. Product Number: 860441. Device will intermittently provide inaccurate data related to native heart rate. Class II Philips North America Llc
Jul 1, 2026 Cardiac Workstation 5000. Product Number: 860439. Device will intermittently provide inaccurate data related to native heart rate. Class II Philips North America Llc
Jul 1, 2026 5-PLASMA Bivalirudin Control, Model Number 5D-44905 Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... Class II Aniara Diagnostica LLC
Jul 1, 2026 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... Class II Aniara Diagnostica LLC
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jul 1, 2026 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... Class II Aniara Diagnostica LLC
Jul 1, 2026 Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class II Stryker GmbH
Jul 1, 2026 Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class II Stryker GmbH
Jul 1, 2026 Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class II Stryker GmbH
Jul 1, 2026 Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class II Stryker GmbH
Jul 1, 2026 Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class II Stryker GmbH
Jul 1, 2026 Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class II Stryker GmbH
Jul 1, 2026 Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class II Stryker GmbH
Jun 30, 2026 GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the ... The module did not undergo electrical safety tests and functional tests during production. Class II Maquet Critical Care AB
Jun 30, 2026 Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: ... Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow... Class II Fresenius Medical Care Renal Therapies Group, LLC
Jun 30, 2026 Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas St... Due to incorrect machining of peripheral screw hole resulting in potential for improper engagemen... Class II restor3d Inc.
Jun 30, 2026 Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 cou... Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... Class II Medline Industries, LP
Jun 30, 2026 Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507;... Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cu... Class I Baxter Healthcare Corporation
Jun 30, 2026 Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Produc... Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... Class II Medline Industries, LP

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.