🏥 Medical Devices • 6,839 recalls
Integra LifeSciences
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Integra York PA
One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
Windstone Medical Packaging
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
Compromised sterility due to breach of barrier
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
American Surgical Company
Product packaging defective compromising sterility
American Surgical Company
Product packaging defective compromising sterility
American Surgical Company
Product packaging defective compromising sterility
American Surgical Company
Product packaging defective compromising sterility
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
American Surgical Company
Product packaging defective compromising sterility
American Surgical Company
Product packaging defective compromising sterility
The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
American Surgical Company
Product packaging defective compromising sterility
American Surgical Company
Product packaging defective compromising sterility
American Surgical Company
Product packaging defective compromising sterility