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TheraHoney wound gel is being recalled after a sterility dose audit failure by the manufacturer. Certain lot numbers are affected. usage of non-sterile gel on open wounds or compromised skin could increase infection risk. Recall start date: May 16,…

Philips Respironics has detected environmental contamination (e.g. External dust and dirt) in the air path of some devices that have been returned from the field. Extended exposure to these environmental contaminants can lead to buildup of particulate on…

BD observed a nonconforming condition where some catheters manufactured had the clear resealing label separating from the product foil pouch, resulting in a possible path into the product packaging that could potentially result in a sterile barrier…

Specific lots of Cemvac revision nozzles are being removed because they were distributed prior to being sterilized. Recall start date: April 24, 2023

A possible process inconsistency was identified for the sterile sheaths from batch# 11130075. At this moment the manufacturer cannot preclude an impairment of the product characteristics. Recall start date: March 15, 2023

Smiths Medical has identified that the Duralife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the Duralife product, the IFU does not provide the cleaning method, duration of autoclave cycle…

Maquet Cardiopulmonary GmbH (MCp) became aware of various failure modes in regard to the Quadrox-I/-Id, vhk 11000 and vkmo 10000/ 11000 products in the course of six non-conformity reports. The identified failure modes can be divided into two categories…

During the execution of 2 year real time aging, an issue was identified during bubble testing where there was a leak in the sealed sterile barrier of the packaging. Further investigation determined the manufacturing work instruction was not aligned to…

BVI has received two complaints from customers that identified an end of the sterile pouch of model #40430 PVA Ultracell Medical Sponges was not sealed. Two lots (21m3820 and 21l3403) have been identified as affected by this failure mode. BVI has…

Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Recall start date: March 1, 2023

Laborie became aware of the damaged packaging through the complaint process. A complaint case was issued in response to a customer complaint involving a small hole found in the film of the sterile barrier of the Injetak needle packaging (dis201). Further…

The Smartbar has the potential to be contaminated with tobacco beetles (lasioderma serricorne). This contamination may lead to patient nausea, emotional changes, or a delay in the procedure which could lead to a delay in diagnosis. Recall start date:…

The affected products were manufactured using unvalidated materials that can result in unsealed packaging for the individual syringes. Recall start date: February 3, 2023

Product was identified as potentially non-sterile as it received an underdose of gamma irradiation during the sterilization process. As the sterilization dose was not achieved, the sterility assurance level cannot be guaranteed. Recall start date:…

Potentially compromised sterile barrier.  The conformity of the products was questioned by the German health authority due to packaging tests not adequately performed.  Single sterilized and transport conditioned according to ASTM d4169-22 was…