# K962205: Sterile and Non-Sterile O.R. Towels, Sterile and Non-Sterile X-Ray Detectable O.R. Towels, Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Nov 26, 1996 after 172 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 7, 2026 · Class II · Z-2124-2026: 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,
- Apr 8, 2024 · Class II · Z-3037-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat
- Dec 7, 2022 · Class II · Z-1125-2023: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- Oct 7, 2003 · Not classified · Z-0114-04: The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.

Source page: https://510kreport.com/device/K962205
Methodology: https://510kreport.com/methodology