Microtek Patient Drape ECOLAB AP6MMN Patient Drape recalled over sterility concerns

Recall date

April 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Microtek Medical, Inc. recalls Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN…

Recall number

Z-1963-2025

FDA classification

Class II

Brand / firm

Microtek Medical, Inc.

Sold / distributed

U.S.: AL. AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, NC, NY, OH, OR, TN, TX, and VA O.U.S.: N/A

Why it was recalled

Due to non-sterile products being labeled as sterile

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.