# FDA recall Z-1963-2025

> **Microtek Medical, Inc.** · Class II · device recall initiated 2025-04-13.

## Product

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.

## Reason for recall

Due to non-sterile products being labeled as sterile

## Distribution

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

## Key facts

- **Recall number:** Z-1963-2025
- **Recalling firm:** Microtek Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-13
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1963-2025

## Citation

> AI Analytics. FDA recall Z-1963-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1963-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*