Drape, Surgical, Antimicrobial
Medline is recalling two surgical drape convenience kits (Model Numbers DYNJ35363A and SPTPCD10005) distributed nationwide because equipment calibration problems during sterilization and packaging may have compromised the sterility of the products. The kits were processed through sterilization cycles, but the calibration issues could potentially reduce their sterility assurance level. This is a Class II recall affecting products distributed across all U.S. states and territories.
- Product
- Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
- 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
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-07
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/dc638b95-4807-4a97-9c7b-ecd20a7daab7