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.
23,781medical device recall records
2,201FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 392
23,781 detailed records are currently available in this category.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a…
Class IIFDA: OngoingNuVasive Specialized Orthopedics, Inc.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
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.