🏥 Medical Devices • 7,015 recalls
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Vortex Surgical
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
The console label for affected devices is missing the "DANGER" symbol.
HANGZHOU BEVER MEDICAL DEVICES CO.
Labeling error, Incorrect expiration date
Medicrea International
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Bard Peripheral Vascular
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Medline Industries
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.