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.
26,628 detailed records are currently available in this category.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105…
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
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.
