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 |
|---|---|---|---|---|
| Apr 15, 2026 | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 1700... | The presence of holes in the pouch may compromise the package s ability to maintain the sterile b... | Class II | Covidien, LP |
| Apr 15, 2026 | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI ... | Due to customer complaint regarding incorrect display box labeling. | Class II | Covidien LLC |
| Apr 14, 2026 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... | A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... | Class II | Dexcom, Inc. |
| Apr 14, 2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... | Class II | Dexcom, Inc. |
| Apr 14, 2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... | Class II | Dexcom, Inc. |
| Apr 14, 2026 | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Mode... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). ... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (RE... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Numbe... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model ... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF)... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (RE... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF)... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Numbe... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Mod... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Mode... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 13, 2026 | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: ... | Due to incorrect incubation process being performed on product. | Class II | HF Acquisition Co LLC |
| Apr 13, 2026 | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: ... | Due to incorrect incubation process being performed on product. | Class II | HF Acquisition Co LLC |
| Apr 13, 2026 | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (X... | Nitrile Exam Glove failed to meet specifications chemical permeation performance. | Class II | O&M HALYARD INC |
| Apr 13, 2026 | LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 ... | Due to a subset of chest compression systems/devices where the service performed on the systems w... | Class II | Jolife AB |
| Apr 13, 2026 | LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 9957... | Some defibrillators serviced between July 2023 through November 2025 were serviced without object... | Class II | Physio-Control, Inc. |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ2... | Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, ... | Class II | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CA... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOL... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYS... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Produ... | Out-of-specification endotoxin result that did not meet the acceptance criteria. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
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.