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.
25,099 detailed records are currently available in this category.
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing…
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Lack of sterility assurance of the 30-0171
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
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.
