All Recalls

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

Due to distributing test kits to customers who were not part of a clinical investigation.

Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Product sterility is potentially compromised.

Product is impacted by a thread profile defect due to a manufacturing issue.

The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.

Display of potential patient movement might be delayed to the user for high dose treatments.

Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.