Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 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 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. |
| Aug 11, 2026 | ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 006901032109... | Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetr... | Class II | Becton, Dickinson and Company |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2026 | PLASTICS TRAY; Model/Item Number (Kit): EURO053; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | HEART PREP TRAY; Model/Item Number (Kit): MECV97W; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | MAJOR PACK; Model/Item Number (Kit): NIHB0018-11; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH1... | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064... | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Ur... | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, ... | Class II | American Contract Systems Inc |
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.