Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 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 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 19, 2026 | Convenience kits containing Medline Namic Angiographic Control Syringes with ... | Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwin... | Class I | American Contract Systems Inc |
| Mar 19, 2026 | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Car... | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... | Class I | Boston Scientific Corporation |
| Mar 19, 2026 | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VA... | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... | Class I | Boston Scientific Corporation |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model ... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Mod... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Mode... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Numb... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. M... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Mod... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 17, 2026 | Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, R... | Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting... | Class I | Medical Action Industries, Inc. 306 |
| Mar 13, 2026 | Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CATH LAB kit. Model Number: SACL75AM. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CATH LAB kit. Model Number: SACL75-01. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 12, 2026 | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula ... | Class I | Insulet Corporation |
| Mar 11, 2026 | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48... | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | Class I | Intuitive Surgical, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, 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 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 18, 2026 | Blue Ventilator Adapter Module, single-patient use circuit, Product Code M079... | Urgent Medical Device Correction for the Volara system single-patient use circuit due to the pote... | Class I | Baxter Healthcare Corporation |
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.