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Since Nov. 2020, Arjo has become aware of 2 customer complaints involving overheating of metal part of the device located underneath its frame. The part involved is referred to as the e-bay box. No adverse health consequences (including temporary or…

Following customers' feedback, we have been able to confirm that the results obtained with this Ih-Qc 3 batch may not be as expected. Different issues were observed which may cause Qc failed results: a. Positive reactions may be observed in Direct…

Since Nov, 2020, Arjo has become aware of 2 customer complaints on smoke and flames coming out of the lift. In both events the extent of flames was limited to the lift and no health consequences were reported. The product (devices and spare parts shipped…

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

Southmedic had engaged an alternative material supplier due to material shortages and was made aware on January 25, 2022 that manufactured and distributed Clearchoice foam face shields have the potential for the presence of latex in the elastic bands of…

Investigations conducted at the manufacturing site identified that the lot may present an elevated risk of leakage from the air-inlet filter of the device. Recall start date: Jan 25, 2022

Investigations conducted at the manufacturing site identified that the lot may present an elevated risk of leakage from the air-inlet filter of the device. Recall start date: Jan 25, 2022

Baxter Corporation is issuing an urgent medical device correction for the Minicap Extended Life Pd Transfer Sets. The following products may cause damage if they come into direct contact with the transfer set: Cleaning products such as hand sanitizer and…

Zimmer Biomet is conducting a medical device recall for one lot of the Navitracker Kit A : Knee product, which is a nonpatient contacting device used during computer and robotic assisted surgeries. The product in scope was released for distribution…

Medtronic has identified eighteen reports where during the advanced evaluation trial period, the percutaneous extension connector has migrated from the future stimulator pocket site along the tunneling pathway. This resulted in difficulty locating the…

Bd has received two (2) complaints reporting that the Bd Veritor Plus analyzer may have the potential to overheat and/or cause fire. Bd's investigation has found that the issue can occur when an unauthorized alternative ac power adapter, and not the one…

Zimmer Biomet is conducting a lot specific medical device recall for the comprehensive shoulder system mini humeral stem. The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that…

Internal testing determined that magnesium failed to meet the interference claim as per ifu for the lipemic serum interference. all lots of magnesium osr6189 are affected.   Recall start date: 2021-12-06…

There is insufficient evidence to support the safety and effectiveness of these face masks. Recall start date: Dec 9, 2021

One shipment of the affected lot was frozen and thawed prior to shipment.   Recall date: 2021-10-07