Browse Device Recalls
39,162 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,162 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 39,162 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 2, 2026 | eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. ... | Class II | Civco Medical Instruments Co. Inc. |
| Mar 2, 2026 | eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. ... | Class II | Civco Medical Instruments Co. Inc. |
| Mar 2, 2026 | eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. ... | Class II | Civco Medical Instruments Co. Inc. |
| Mar 2, 2026 | eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. ... | Class II | Civco Medical Instruments Co. Inc. |
| Mar 2, 2026 | eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. ... | Class II | Civco Medical Instruments Co. Inc. |
| Mar 2, 2026 | eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. ... | Class II | Civco Medical Instruments Co. Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor | Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (C... | Class II | Spacelabs Healthcare, Inc. |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1... | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Sy... | Class II | Cardinal Health 200, LLC |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTI... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: S... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
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.