🏥 Medical Devices • 4,262 recalls
Stryker Instruments Div. of Stryker
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker Instruments Div. of Stryker
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.
There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
Centurion Medical Products
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
Centurion Medical Products
Convenience Kit containing components to assist practitioner with IV placement and securement.
Centurion Medical Products
Convenience Kit containing components to assist practitioner with IV placement and securement.
Centurion Medical Products
Convenience Kit containing components to assist practitioner with IV placement and securement.
The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist.
Centurion Medical Products
Convenience Kit containing components to assist practitioner with IV placement and securement.
This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.
Centurion Medical Products
Convenience Kit containing components to assist practitioner with IV placement and securement.
Contact lenses lack sterility assurance.
Vygon MFG, Inc., dba/ Churchill Medical Systems
The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.
Contact lenses lack sterility assurance.
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
Contact lenses lack sterility assurance.
Contact lenses lack sterility assurance.