# FDA recall Z-2221-2024

> **ASPEN SURGICAL** · Class II · device recall initiated 2024-06-03.

## Product

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

## Reason for recall

The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-2221-2024
- **Recalling firm:** ASPEN SURGICAL
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-03
- **Report date:** 2024-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Caledonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2221-2024

## Citation

> AI Analytics. FDA recall Z-2221-2024. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-2221-2024. Source: US FDA. Licensed CC0.

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