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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.