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An increase in complaints related to incomplete seals or the dressing been trapped in packaging was observed. As a potential hazard associated with these complaints involve the dressing being open or the product being sealed within the same primary…

Avanos medical is conducting a voluntary field correction for the Cortrak* 2 Enteral Access System (Eas) because modifications to the labeling of the device have been initiated. Reports of injuries and patient deaths related to misplacement of…

This recall notice describes a labelling update to correct the instructions for use for the flexible endoscopes identified to advise that high-level disinfection and, for specific models, liquid chemical sterilization, should not be used as methods of…

Stryker has discovered (via complaint trending initiated February 2022) that any one of the following product markings on the Triathlon® primary and Tritanium tibial baseplates listed above may be incorrect: catalog number, lot number, and/or size (2…

Baxter Corporation has received one complaint of a customer getting self-righting luer lock tip caps, yellow (product code h938690025) mislabeled as self-righting luer slip tip caps, yellow (product code h93866100). Recall start date: Feb 28, 2022

Through investigation following a product complaint (December 15 2021), Stryker has discovered a potential product mix where the size and/or offset of the Biolox® Delta Ceramic V40™ femoral head inside the package does not match the package labeling.…

The Curad Hot/Cold gel pack with wrap currently has the labeling states "does not contain natural rubber latex". However, the fabric around the gel pack does contain some natural rubber latex. The fabric wrap contains 20% latex thread. There is a risk of…

The outer pouch packaging of the product may not be sealed. The product is provided sterile within an inner pouch, which is placed within an outer pouch. A single unit of another product from the same lot was found with an open seal during final…

When we imported these items 18 months ago, we provided the test results for the KN95 but later learned these results were from the correct manufacturer but for a different model or size. We have no reason to suspect they are bad but now…

Cardinal health is conducting this recall due to the potential for open packaging seals for sterile surgical gowns. The investigation isolated the issue to gowns manufactured on a singular packaging line. The recall is being initiated on…

The Hemostasis valve in the closed position is not fully sealed and additional steps are required to prevent air ingress. Abbott is providing instructions (including update to the product instructions for use [IFU] and additional product…

The tubing sets are designed and labeled for 2 years shelf-life from the manufacturing date. However, during a review of the technical documentation of tubing sets, it was found out that there is not sufficient evidence to demonstrate…

This labeling correction involves revising the catheter IFU to include warning/caution statements about potential health risks due to overloading of the Sterile Saline fluid. This recall only affects the IFU; not the Catheters.   Initial…