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.
25,676 detailed records are currently available in this category.
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power…
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and…
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are…
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power…
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and…
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to…
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power…
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.
