Browse Device Recalls
39,885 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,885 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 39,885 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 13, 2026 | Blanketrol II Model 222S; Thermal regulating system. | Overheating of the 115V CPU board may cause the device to shut down. | Class II | Gentherm Medical, LLC |
| Jul 13, 2026 | Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x ... | Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine As... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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 | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Cat... | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... | Class III | Paragon 28, Inc. |
| Jul 10, 2026 | Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catal... | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... | Class III | Paragon 28, Inc. |
| 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 | 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 | 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 | 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 |
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.