All Recalls

Complaints of the ceramic tip of the resection sheath breaking have been received.

Software anomaly in the patient positioning system may result in positional discrepancy.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Lack of 510K clearance

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Potential contamination with leachable lead.

Potential contamination with leachable lead.

Potential to be contaminated with Salmonella

Label declares bovine colostrum but does not declare milk allergen.

Undeclared fish allergen (tuna). Tuna Salad was mislabeled as Chicken Salad.

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)

Potential contamination with leachable lead.

Potential contamination with leachable lead.

Possible presence of Foreign Material

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.