# FDA recall Z-1366-2021

> **Sharp Medical Products** · Class II · device recall initiated 2021-02-08.

## Product

SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

## Reason for recall

Non-conformity (holes/punctures or deep creases) in the sterile barrier.

## Distribution

U.S.:  AZ, FL, MI, OH, TX, and WI.    O.U.S.: None

## Key facts

- **Recall number:** Z-1366-2021
- **Recalling firm:** Sharp Medical Products
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-08
- **Report date:** 2021-04-14
- **Termination date:** 2023-02-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Scottsdale, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1366-2021

## Citation

> AI Analytics. FDA recall Z-1366-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1366-2021. Source: US FDA. Licensed CC0.

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