FDA medical device recalls

The plus and minus buttons used to control light intensity on Steris ALYON Surgical Lighting System light heads may detach during use. This affects 549 units distributed nationwide. No injuries have been reported.

The plus and minus buttons (+/-) on the light heads of Steris HarmonyAIR A-Series Surgical Lighting Systems may detach during use. This could affect the ability to control light intensity in the operating room. No injuries have been reported.

Paint on the light heads of Steris HarmonyAIR A-Series Surgical Lighting Systems may chip or peel. This could potentially affect the lighting system's performance or introduce debris into the surgical field. The FDA has classified this as a Class II recall.

Medline convenience hysterectomy kits contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. The butyrate tubing in these kits may crack when used, making the adhesive unusable for application.

Medline convenience kits used in C-section procedures contain a recalled adhesive product with defective tubing that may crack during use, making the adhesive unusable. The affected kits were distributed nationwide. No injuries have been reported.

Medline convenience kits contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive with defective tubing. The butyrate tubing in these kits may crack when used, making the adhesive unusable for medical application.

Multiple Medline surgical convenience kits contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive where the tubing may crack during use, making the adhesive unusable. This affects kits used in cardiac, vascular, and pacemaker procedures.

Medline convenience kits for port-a-cath procedures contain a recalled batch of MASTISOL Liquid Adhesive from Ferndale Laboratories. The tubing in these kits may crack during use, making the product unusable.

Medline femoral block tray kits (model DYNJRA1739B) contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. The tubing in these adhesive applicators may crack when used, making the product unusable for its intended application.

Medline surgical convenience kits contain a recalled lot of Mastisol Liquid Adhesive from Ferndale Laboratories. The adhesive's butyrate tubing can crack during use, making the product unusable in surgical settings. No injuries have been reported.

Medline convenience kits (Driveline Management Kit EBSI1688 and Port Dressing Change Kit EBSI1328A) contain a recalled adhesive product with defective tubing. The tubing may crack when used, making the adhesive unusable. About 49,600 kits have been distributed nationwide.

Medline convenience kits containing central venous catheter (CVC) insertion supplies include a recalled lot of adhesive that can cause the tubing to crack when used. This may render the kit unusable for the intended medical procedure. No injuries have been reported.

Several Medline convenience kits used for central line, PICC, dialysis, and port access dressing changes contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive. The tubing in these adhesive bottles may crack when used, making the product unusable.

Medline Industries' Centurion convenience kits—used for central line, dialysis, and port dressing changes—contain a recalled batch of Mastisol Liquid Adhesive with defective tubing. The tubing may crack when squeezed, making the adhesive unusable for patient care.

Medline Industries is recalling over 49,000 surgical convenience kits that contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive. The tubing in the adhesive applicator may crack during use, making the product unusable in the operating room.

Medline convenience kits (Basic Eye and Tubal Ligation models) contain a recalled adhesive product from Ferndale Laboratories. The tubing in the adhesive applicator may crack when used, making the kit unusable.

Medline convenience kits (model DYNJ908031D) contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive. The butyrate tubing in these adhesive bottles may crack when used, making the product unusable. No injuries have been reported.

Medline convenience kits contain a recalled lot of MASTISOL Liquid Adhesive from Ferndale Laboratories. The butyrate tubing in these kits may crack during use, making the adhesive unusable.

Medline convenience kits contain a recalled lot of MASTISOL Liquid Adhesive from Ferndale Laboratories. The tubing in the adhesive may crack when used, making the product unusable.

Medline convenience kits used in robotic and laparoscopic surgery contain a recalled lot of adhesive from Ferndale Laboratories. The tubing in the adhesive applicator may crack during use, making the product unable to be applied properly during surgery.

Medline's SMSC-PELVISCOPY convenience kits contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive. The tubing in these kits may crack when used, making the adhesive unusable for its intended application.

Medline convenience kits used in labor and delivery and C-section procedures contain a recalled lot of MASTISOL Liquid Adhesive from Ferndale Laboratories. The tubing in these adhesive bottles may crack when used, making the product unable to be applied properly.

Medline Industries recalled multiple neurosurgery convenience kits because they contain a defective lot of MASTISOL Liquid Adhesive from Ferndale Laboratories. The tubing in the adhesive applicator may crack when used, making the product unusable for the procedure.

Medline convenience kits for hernia repair contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. The butyrate tubing in these kits may crack when used, making the adhesive unusable for its intended application.

Medline's pediatric dressing change convenience kit contains a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive with a manufacturing defect. The tubing may crack when you try to use it, making the adhesive unusable.

Medline's IV Start Kit with HubGuard (model DYNDV2662) contains a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive. The butyrate tubing in these kits may crack when used, making the kit unusable for its intended purpose.

Medline convenience kits containing a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive are being recalled. The adhesive's butyrate tubing can crack during use, making the adhesive unusable in surgical settings. About 50,000 kits across multiple surgical types are affected.

Medline's plastic surgery convenience kits contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive with a manufacturing defect. The adhesive's butyrate tubing may crack when used, making the product unable to function properly during surgery.

Medline Industries distributed multiple surgical convenience kits containing a recalled lot of Mastisol Liquid Adhesive from Ferndale Laboratories. The adhesive tubing may crack when used, making the product unusable during procedures.

Medline Industries issued a recall of nearly 50,000 surgical convenience kits because they contain a defective lot of Mastisol Liquid Adhesive made by Ferndale Laboratories. The tubing on the adhesive dispenser may crack when used, making the product unusable during surgery.