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.
27,110 detailed records are currently available in this category.
Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
Product sterility may be compromised due to unsealed packaging.
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle…
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
There is a potential for a software issue that may cause the need for necessary patient rescans.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle…
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Product sterility may be compromised due to unsealed packaging.
Product sterility potentially compromised.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
There is a potential for a software issue that may cause the need for necessary patient rescans.
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Product sterility may be compromised due to unsealed packaging.
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.
