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Specific lots have the potential for a broken sled vane component. A broken sled vane may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may…

In the course of internal quality controls, Draeger has noticed that some of their flex ventilation hoses have contaminations. Due to a deviation in the manufacturing process, components of the hose material remained as particles inside the hoses.…

Baxter Corportation is issuing a recall for certain lots of the Minicap. These devices are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals.  Recall start date: February 01, 2023

Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 48-month stability testing timepoint.

Convatec is conducting a medical device recall for a specific lot of Aquacel® Ag foam adhesive 10cm x 10cm due to the visual contamination in the form of brown spots present on dressings. An internal investigation determined that the likely root cause…

During the investigation process of customer complaints, Lina has become aware of a safety issue in relation to the use of an obsolete version of an accompanying document. The use of an obsolete customer quick reference guide resulted in the incorrect…

Medline 3" walker wheels with glide caps can potentially come with a loose acorn nut that attaches the wheel to the leg. Health consequences include the chances of the wheel becoming loose and disconnecting resulting in an unstable condition of the…

Hologic has received a single report of a c-arm performing a significant unexpected movement during non-patient related use of the system. The investigation determined this event was due to a hardware component failure. Recall start date: January 16,…

Through ongoing internal testing, Baxter Corporation has observed isolated incident of over infusion on the Novum IQ LVP infusion pump during test runs at 0.1 ml/hr after 40 hours of continuous infusion within the 96-hour set change interval. Baxter…

Affected lots may contain the presence of Cronobacter contamination.

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:…

Non-licensed inventory was sent to Canada via web shop orders starting in February of 2022. Recall start date: December 12, 2022

Affected lots may contain the presence of foreign matter.

During internal studies with the Elecsys® Troponin T hs (high sensitive) and Elecsys® Troponin T hs Stat assays, it was confirmed that for certain k2/k3 EDTA primary tubes, TnT hs results are elevated compared to serum samples when measured…

Beckman Coulter has determined that the Access 2 wash arm lead screw nut band is susceptible to breakage. An Access 2 Immunoassay system wash arm may not move as intended if the nut band is broken. A broken nut band may increase the risk of erroneous…