Medline Convenience Kits: 1) Endo Kit W/syringe, Model Number: Dyke1743; 2) Bgmc Angiography Pack-lf, Model Number: Dynj0800934d; 3) General Endo Pack-lf, Model Number: Dynj0842873j; 4) Or Angi

Recall Summary Medline is recalling ten models of surgical and medical convenience kits used in hospitals and medical facilities. The kits were sterilized and packaged using equipment that had calibration problems, which could potentially affect whether the products are properly sterilized. These products were distributed to healthcare facilities.

Product

Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066A; 6) SOUTH CATH LAB PACK, Model Number: DYNJ61978A; 7) BIOPSY ANGIO TRAY ALEX, Model Number: DYNJ63542B; 8) SURGICAL TECH KIT, Model Number: DYNJ907452; 9) ANGIOGRAPHY PACK, Model Number: DYNJC2371G; 10) SPECTRUM HEALTH CATH PACK-LF, Model Number: PHS853965G

Reason

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/72bb024a-11e9-4645-9cfc-c92c8679ef7c