Search

Mold was found in lot Y591676 of the product. Two species of mold were identified that could pose a potential health risk to users. Recall start date: May 3, 2022

The recall activities are being conducted due to several temperature excursions on inbound shipment to Canada.  According, to the assessment by the manufacturer, Anteis S.A, no data is available for Belotero products after repeated freezing and…

The Universal Plus™ Laparoscopic Electrodes devices are sold as single use, sterile devices. Conmed received reports that the tip of the electrode could detach during use. Recall start date: Apr 19, 2022

A review of complaints on Sureform PNs 480445, 480545, 480460 was done to determine rate of harm due to tissue pushout events. This action was completed as part of an internal capa. Sureform complaint data from October 1, 2019 through September 30, 2021…

Potential non-recoverable error during Arm Cart Assembly calibration self-test leading to a delay to the surgical procedure. Recall start date: Mar 21, 2022

On February 28, 2022, the manufacturer discovered that the endotoxin concentration of the product in some samples has been measured above the limit. Recall start date: Mar 8, 2022

The product license is on hold/suspended due to the missing MDSAP certification from the supplier Biomed. Since there is no MDSAP certification the products are not meeting the regulatory requirements of the act or MDR for Health Canada (Medical Devices…

A small number of implants may have a potential weakened shell on the patch area which may result in premature deflation.

During verification testing, a non-conformance was detected. Failure mode was uncontrolled leakage of glue from the distal tip of the Fix8 open (FX002) device. Recall start date: Feb 3, 2022

During verification testing, a non-conformance was detected. Failure mode was uncontrolled leakage of glue from the distal tip of the Fix8 Open (FX002) device. Recall start date: Feb 3, 2022

Reports received of a small hole or damage in the area of the maple leaf symbol in the corner of the healthy apparel disposable masks. Recall start date: Jan 24, 2022

Hillrom received four (4) complaints between 29-Sep-2020 and 09-Apr-2021 of the Slingbar 450 becoming detached from the upper bracket of the Slingbar attachment on Liko M230 Mobile Lifts. The Slingbar is attached to the lifting arm through two brackets.…

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…

On November 22, 2021 via customer complaint - Stryker became aware the inside the packaging of one reported item #81032 (Titan OFW-MTB, right) a non-conforming product was found. Contrary to the design, the barrier layer was manufactured…

Cardinal Health has initiated a medical device correction for specific production lots of nonabsorbent towels with adhesives manufactured between March 2021 and October 2021 due to varying levels of adhesion. Affected non-absorbent towels are supplied in…