Complete FDA and NHTSA recall records dated in June 2021.
These records include useful source details for the selected month.
Due to distributing test kits to customers who were not part of a clinical investigation.
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
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.
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.
Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that…
The devices may not meet the minimum required sterility assurance level.
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
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.
Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing…
Due to distributing test kits to customers who were not part of a clinical investigation.
Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
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.
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…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
