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.
23,781 detailed records are currently available in this category.
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure…
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
The packaging may not be sealed, which could compromise sterility.
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that…
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the…
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will stop…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile…
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.
