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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.

23,306medical device recall records
2,192FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.745 records
Database records

Records — page 336

23,306 detailed records are currently available in this category.

Medical DeviceAug 23, 2023

Alcon Custom Pak recall — FDA Z-2411-2023

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Class IIFDA: OngoingAlcon Research, LTD.

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.