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Sheathes Pre-Gelled

SHEATHING TECHNOLOGIES, INC. · Model 27380-PT · UDI-DI 10842418102498

510(k) clearances

Adverse events

Recalls

Facilities

Description

27380-PT, Each, Polyurethane, 1"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Prove Cover, Vaginal/Rectal, Tapered, Un-Rolled with Pull Tab, Extra-Long, Individually Wrapped

Recalls

Date	Firm	Reason
2025-09-04	American Contract Systems Inc.	Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not
2023-08-16	Cardinal Health 200, LLC	Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
2022-03-22	American Contract Systems, Inc.	Product was sterilized with a higher than specification EO concentration.
2021-08-10	ROi CPS LLC	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
2021-08-10	ROi CPS LLC	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.