🏥 Medical Devices • 6,839 recalls
C.R. Bard
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
Resource Optimization & Innovation
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Resource Optimization & Innovation
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Resource Optimization & Innovation
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Resource Optimization & Innovation
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Resource Optimization & Innovation
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Resource Optimization & Innovation
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Resource Optimization & Innovation
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Resource Optimization & Innovation
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Some 1 1/4" needles were packaged and labeled in the 1" blister package.
Baxter Healthcare
Potential for a leak at the tubing to luer bond.
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Biomet Microfixation
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Biomet Microfixation
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Arrow International
Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.