Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 18, 2026 | Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labe... | Increased risk of purge leaks with Generation 1 purge cassettes. | Class I | Abiomed, Inc. |
| Feb 18, 2026 | Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by ... | If heating pad is folded while in use, the power density increases in the folded area causing exc... | Class I | Navajo Manufacturing Company |
| Feb 16, 2026 | Automated Impella Controller (AIC), labeled as the following with correspondi... | Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC... | Class I | Abiomed, Inc. |
| Feb 13, 2026 | DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A,... | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... | Class I | Merit Medical Systems, Inc. |
| Feb 13, 2026 | BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021... | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... | Class I | Merit Medical Systems, Inc. |
| Feb 13, 2026 | 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-17... | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... | Class I | Merit Medical Systems, Inc. |
| Feb 13, 2026 | ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452... | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... | Class I | Merit Medical Systems, Inc. |
| Feb 13, 2026 | CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, C... | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... | Class I | Merit Medical Systems, Inc. |
| Feb 12, 2026 | Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use | Probes may rupture/burst during activation | Class I | Erbe USA Inc |
| Feb 12, 2026 | Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use | Probes may rupture/burst during activation | Class I | Erbe USA Inc |
| Feb 12, 2026 | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: ... | Probes may rupture/burst during activation | Class I | Erbe USA Inc |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, 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.