Browse Device Recalls

35,226 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,226 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 35,226 FDA device recalls, Class II.

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DateProductReasonClassFirm
Jul 13, 2026 Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NE... Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... Class II Medline Industries, LP
Jul 13, 2026 OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Sm... There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which... Class II OBP Medical Corporation
Jul 13, 2026 GM Helix Implant, Endosseous Dental Implant Article No. 109.984 There may be a mismatch between the implant contained inside the packaging and the information de... Class II Straumann USA LLC
Jul 10, 2026 Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; ... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SK... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU C... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU C... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU ... Component labeling discrepancy Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DY... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU C... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visua... The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation,... Class II AVID Medical, Inc.
Jul 10, 2026 Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline K... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS98... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitor... A software vulnerability may allow unauthorized persons to gain privileged access to the device, ... Class II GE Medical Systems Information Technologies Inc
Jul 9, 2026 Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product... 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 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 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 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 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 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

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.