Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or...
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Fixone Hybrid Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER ...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOO...
Potential exposure of rodents and rodent activity in the distribution center.
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 100...
due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Genesis Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
AlternatiV+ Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Genesis Push-In Suture Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY ...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT ...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with S...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW versi...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Ki...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisT...
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
Genesis Dual Thread Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Genesis Knotless Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit S...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape M...
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet S...
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Mo...
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWA...
Potential exposure of rodents and rodent activity in the distribution center.
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/C...
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.