Browse Device Recalls
40,358 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 40,358 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 40,358 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 18, 2026 | CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial ... | Screws, intended for use with polyaxial compression plating system intended for foot osteotomies,... | Class II | Wright Medical Technology, Inc. |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used wit... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | In-Line Valve, Product Number: P5-TEE | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x,... | The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots ma... | Class II | Philips North America Llc |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Pha... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasit... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) us... | There is an error in the product description on the Unique Device Identification (UDI) label. The... | Class II | Baxter Healthcare Corporation |
| Aug 18, 2026 | PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technolog... | There is an error in the product description on the Unique Device Identification (UDI) label. The... | Class II | Baxter Healthcare Corporation |
| Aug 18, 2026 | PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) us... | There is an error in the product description on the Unique Device Identification (UDI) label. The... | Class II | Baxter Healthcare Corporation |
| Aug 18, 2026 | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Doubl... | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. | Class II | Olympus Corporation of the Americas |
| Aug 17, 2026 | MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, R... | Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, L... | Class II | Microgenics Corporation |
| Aug 17, 2026 | Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN)... | The potential for falsely elevated results. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2026 | Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs ... | The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the fro... | Class II | Medline Industries, LP |
| Aug 14, 2026 | Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and ... | The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the fro... | Class II | Medline Industries, LP |
| Aug 14, 2026 | Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Num... | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... | Class II | American Nitrile Operations Llc |
| Aug 14, 2026 | Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog N... | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... | Class II | American Nitrile Operations Llc |
| Aug 14, 2026 | Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand P... | Potential fire hazard involving the hand control pendant and associated wiring used with affected... | Class I | Medline Industries, LP |
| Aug 14, 2026 | Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Num... | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... | Class II | American Nitrile Operations Llc |
| Aug 14, 2026 | Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR1... | Potential fire hazard involving the hand control pendant and associated wiring used with affected... | Class I | Medline Industries, LP |
| Aug 13, 2026 | BD Phoenix Panel NMIC-306. Catalog Number: 449292. | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CP... | Class II | Becton Dickinson & Co. |
| Aug 13, 2026 | BD Phoenix Panel NMIC-312. Catalog Number: 449082. | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CP... | Class II | Becton Dickinson & Co. |
| Aug 12, 2026 | Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia ... | Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... | Class II | BioFire Diagnostics, LLC |
| Aug 12, 2026 | Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumo... | Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... | Class II | BioFire Diagnostics, LLC |
| Aug 12, 2026 | IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 S... | The rinse-line check valve has a shorter service lifespan than originally expected and requires a... | Class II | Beckman Coulter, Inc. |
| Aug 12, 2026 | Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Join... | Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... | Class II | BioFire Diagnostics, LLC |
| Aug 12, 2026 | Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue c... | Medtronic identified through donor record review that the donor for Medtronic batch A62881 did n... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 12, 2026 | DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513 | The rinse-line check valve has a shorter service lifespan than originally expected and requires a... | Class II | Beckman Coulter, Inc. |
| Aug 12, 2026 | Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue co... | Medtronic identified through donor record review that the donor for Medtronic batch A62881 did no... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 12, 2026 | HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL S... | Due to incorrect inside packaging label for eyepiece. | Class II | Karl Storz Endoscopy |
| Aug 12, 2026 | Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens M... | A small number of lenses within the affected lot are of the incorrect power. | Class II | CooperVision, Inc. |
| Aug 12, 2026 | Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT00... | Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). | Class II | INTERVASCULAR, SAS |
| Aug 12, 2026 | GM Helix Implant, REF: 109.984; | There is a discrepancy between the product identification on the packaging and the dimensions of ... | Class II | Straumann USA LLC |
| Aug 12, 2026 | Impella Optical Controller, Automated Impella Controller, Impella Connect Pac... | The potential for purge cassette recognition issues due to the failure of the purge flag componen... | Class I | Abiomed, Inc. |
| Aug 12, 2026 | Impella Optical Controller with the below product descriptions and correspond... | The potential for purge cassette recognition issues due to the failure of the purge flag componen... | Class I | Abiomed, Inc. |
| Aug 12, 2026 | Automated Impella Controller (AIC) with the below product descriptions and co... | The potential for purge cassette recognition issues due to the failure of the purge flag componen... | Class I | Abiomed, Inc. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI 780 | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550 w... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 760 with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panor... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panv... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT ATLAS Astound with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT ATLAS with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 780 with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panvi... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panor... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 550 with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 530 with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
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.