Medline Surgical Packs: 1) Pack,universal,ultragard,5/cs, Model Number: Dynjp1050ug; 2) Pack,shoulder,drape,pouch,10/csmodel Number: Dynjp8401
Surgical Pack Recall Summary Medline is recalling two types of surgical packs (Universal UltraGard packs and Shoulder Drape Pouch packs) due to calibration problems with the sterilization and packaging equipment used to process them. The calibration issues could potentially affect whether these products meet required sterility standards. This is classified as a Class II recall.
- Product
- Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
- 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/1c3f80ac-c5eb-4ee2-b8ed-3bbed0d89185