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.
28,992 detailed records are currently available in this category.
Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of…
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during…
Product packaging defective compromising sterility
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product…
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
Product packaging defective compromising sterility
Product packaging defective compromising sterility
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up…
Product packaging defective compromising sterility
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Product packaging defective compromising sterility
Product packaging defective compromising sterility
The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
Product packaging defective compromising sterility
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product…
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product…
Product packaging defective compromising sterility
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product…
Product packaging defective compromising sterility
Product packaging defective compromising sterility
Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from…
Product packaging defective compromising sterility
Product packaging defective compromising sterility
Product packaging defective compromising sterility
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.
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.
