Search

In the course of post market surveillance activities and our internal quality checks, we identified that the sterile packaging barrier might be damaged for certain batches. Recall Start Date: August 7, 2023

Medline recalls sterile 4.5" iris scissors (dynj04049); tip protector may detach, risking unseen punctures in the sterile barrier. Recall start date: August 11, 2023

Cardinal Health Canada has been notified of an urgent product recall initiated by Ecolab for the equipment drapes, table cover, and surgical room turnover (SRT) kits. Ecolab as Microtek has received odor complaints on certain lots. The odor has been…

The packaging containing a pair of sterilized surgical gloves is not sufficiently sealed potentially compromising the sterility assurance of the product. Recall start date: August 3, 2023

Due to a failed revalidation of the sterilization process, there is no proof of the sterility of the products. The hazardous situation, that a contaminated product is used could lead to the consequence of patient infection. There is no subsequent risk…

Manufacturer notification to highlight the following changes: 1. Change conditions for ethylene oxide (EtO) gas sterilization from 12% EtO to 100% EtO. 2. Reusable cleaning brush are no longer compatible for the manual cleaning. single use brushes…

There is currently a non-conformance regarding the disinfection method recommended in the instructions manual for devices in the field, as the Keredusy disinfection method was not adequately validated. Long term effects of this method on the device…

The reason for the recall is that the products were contaminated with naphthalene during shipment. Lab testing found naphthalene to be present on the product packaging and the device itself. Recall Start Date: June 23, 2023

Medtronic was informed by the contract manufacturer that based on internal investigation they have identified issues with in-process and finished goods endotoxin testing. these issues may have resulted in the release of product with out-of-specification…

Surgical procedure trays are recalled because Medline is unable to confirm the sterility of the ultrasound gel which may lead to an increase of infection if used on breached/compromised skin. Recall start date: May 30, 2023

Medline Industries is recalling specific probe cover kits due to unconfirmed sterility of the ultrasound gel and potential inadequacy of the probe cover seams, which could increase infection risk. Recall start date: June 1, 2023

Certain lots of sharp, blunt 5.5 in or scissors were manufactured without tip protectors allowing the scissors to potentially break through the semi-rigid plastic tray compromising sterility and adding risk of injury to users. Recall start date: May…

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…