FDA public records

Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

1,218medical device recall records
208FDA Class I records
8firms with 5+ records
Medline Industries, LP316 records
Database records

Records — page 28

1,218 detailed records are currently available in this category.

Medical DeviceMay 20, 2026

Dexcom ONE+ iOS CGM App recall — FDA Z-2165-2026

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is…

Class IIFDA: OngoingDexcom, Inc.
Medical DeviceMay 20, 2026

Jolife AB LUCAS 2 recall — FDA Z-2161-2026

Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the…

Class IIFDA: OngoingJolife AB
Medical DeviceMay 13, 2026

Medline Convenience Kits: 1) PPE KIT recall — FDA Z-2104-2026

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging…

Class IIFDA: OngoingMedline Industries, LP

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.