Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.
Showing 841–860 of 1,000 recalls
Aspen Surgical Products, Inc.
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Baxter Healthcare Corporation
Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming