Medical device recalls

Philips has recalled certain Ingenia 1.5T MRI systems with software versions R11.1 and R12.1. When MR Elastography stiffness maps are exported to a PACS viewer, the stiffness values may display incorrectly. This could affect the accuracy of diagnostic information viewed in those systems.

Philips MR systems (Evolution Upgrade 3.0T, software versions R11.1 and R12.1) may display incorrect stiffness values when MR Elastography maps are exported to a PACS viewer system. This could affect the accuracy of imaging data used in clinical assessment.

Philips Evolution Upgrade 1.5T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography maps are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used in clinical diagnosis. Three units have been identified worldwide.

Cardinal Health is updating instructions for multiple chest drainage unit models to clarify they are intended only for adults 18 years and older. When used on infants, these devices may not show proper bubbling or fluid movement, which can make it hard for clinicians to tell if the device is working correctly. This could delay or prevent needed treatment.

The touchscreen on certain Zimmer A.T.S. 3200TS tourniquet systems may freeze or stop responding when the device is set to operate in certain non-English languages. This could delay surgery while staff locate an alternate device. The issue affects systems running software version 2.06 or earlier.

The screen on Zimmer A.T.S. 5000TS Tourniquet Systems may freeze or stop responding when used in certain non-English language settings. This can delay surgery while staff locate an alternate device. The issue affects systems running software version v2.04 or earlier.

Medline medical procedure convenience kits containing MASTISOL liquid adhesive were recalled because the tubing can crack when the adhesive vial is opened. This could prevent proper use of the adhesive during surgery. No injuries have been reported.

Medline distributed three types of medical procedure kits containing MASTISOL liquid adhesive where the tubing can crack when the vial is opened. This could prevent proper adhesive application during cesarean section procedures. No injuries have been reported.

Medline distributed circumcision procedure kits (SKU DYNJ16826O) that contained MASTISOL liquid adhesive with a manufacturing defect. The tubing on the adhesive vials can crack when opened, which could affect the sterility and usability of the adhesive during the procedure.

Medline distributed medical procedure convenience kits containing MASTISOL liquid adhesive with a manufacturing defect. The adhesive vials have butyrate tubing that can crack when opened, potentially compromising the adhesive's sterility and usability during procedures.

Medline distributed six types of neurosurgery procedure convenience kits containing MASTISOL liquid adhesive. The tubing in the adhesive vials can crack when opened, which may compromise the sterility or usability of the kit. No injuries have been reported.

Medline medical procedure convenience kits containing MASTISOL liquid adhesive were distributed with a manufacturing defect. The butyrate tubing in the adhesive applicator vials can crack when used, potentially affecting the adhesive's delivery or safety during medical procedures.

Medline medical procedure convenience kits (SKU P903933B) contain MASTISOL liquid adhesive with defective tubing that can crack when the vial is used. The cracked tubing could prevent proper product delivery during medical procedures.

Medline distributed 66 different medical procedure kits containing MASTISOL liquid adhesive with defective butyrate tubing that can crack when the vial is opened. The adhesive is used to secure medical devices during surgical procedures. No injuries have been reported.

Medline distributed eight types of medical procedure convenience kits that contained MASTISOL liquid adhesive with a manufacturing defect. The tubing in the adhesive vials can crack when opened, which could affect the sterility or usability of the kit during medical procedures.

Medline distributed 30 types of surgical procedure convenience kits that contained MASTISOL liquid adhesive with a manufacturing defect. The tubing on the adhesive vials can crack when opened, potentially affecting the sterility of the kit. About 456 affected kits were distributed; no injuries have been reported.

Medline distributed nine types of medical procedure convenience kits containing MASTISOL liquid adhesive. The adhesive vials have defective tubing that can crack when used, potentially compromising the sterility and function of the kits. About 40 units were affected.

Medline distributed three medical procedure convenience kits containing MASTISOL liquid adhesive with a defect: the tubing can crack when the adhesive vial is opened. This affects breast-hernia-port, breast biopsy, and dermatology procedure kits. No injuries have been reported.

Medline distributed eight types of medical procedure convenience kits containing MASTISOL liquid adhesive. The adhesive vials had cracked butyrate tubing that could break when the vial is opened, potentially affecting the sterility or usability of the kit.

Medline medical procedure kits containing MASTISOL liquid adhesive were distributed with a defect: the tubing inside the adhesive vials can crack when opened. This affects two kit types used in cardiac catheterization and loop recovery procedures. No injuries have been reported.

Medline's Nerve Block Tray 2 kits contain MASTISOL liquid adhesive vials with tubing that can crack when opened. The cracked tubing could cause the adhesive to leak or not function as intended during medical procedures.

NIPRO Technical Services' Conductivity Standard Solutions (models 10001, 10011, 10021, 10032, 10040, 10040c, 10041) have a defect that causes incorrect conductivity readings. These solutions are used to calibrate meters that measure dialysate (the fluid used in dialysis treatment). If calibration is inaccurate, dialysis machines may report wrong conductivity values, which could affect treatment safety.

Gold Star Distribution pregnancy test kits (24-count) may have been exposed to rodents or rodent activity at a distribution center. The FDA is recalling the product due to potential contamination concerns.

Toothbrushes and toothbrush-paste kits distributed by Gold Star Distribution were exposed to rodents and rodent activity at a distribution center. The affected products include Oral-B Shiny Clean Soft, Colgate Medium, and adult toothpaste-with-brush kits in whitening and cavity-prevention formulas.

Several feminine hygiene product brands distributed by Gold Star Distribution Inc. may have been exposed to rodents and rodent activity at a distribution center. The affected products include Kotex, Always, Julie, Stay Free, and Tampax brands. No injuries have been reported.

Trojan condoms from multiple product lines were stored in a distribution center where rodents and rodent activity were detected. The condoms may have been exposed to contamination. No injuries have been reported.

Gold Star Distribution first aid kits and bandages may have been exposed to rodents or rodent activity at a distribution center. The affected products include FIRST AID KIT 24/42PC and LUCKY FIRST AID BANDAGES 24CT distributed in Minnesota. No injuries have been reported.

Fixing screws on the ceiling movement gear of Canon Medical Alphenix INFX-8000V interventional X-ray systems may loosen over time. This can prevent the ceiling arm from moving side-to-side, cause unusual noises from the suspension system, or trigger sensor errors on the equipment.

Fixing screws on the ceiling-mounted arm of certain Canon Medical Alphenix X-ray systems may become loose. This can prevent the arm from moving side to side, cause unusual noise, or trigger error messages. Three units worldwide are affected.

Fixing screws on the ceiling movement gear in Canon Medical's Alphenix INFX-8000F X-ray systems may become loose over time. This can prevent the ceiling arm from moving side to side, cause unusual noises, or trigger sensor errors during procedures.