# FDA recall Z-2679-2026

> **Oscor Inc.** · Class I · device recall initiated 2026-06-10.

## Product

Abiomed REF: 0052-3021, Introducer Kit for Impella   Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.

## Reason for recall

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

## Distribution

Distribution in the US state of MA

## Key facts

- **Recall number:** Z-2679-2026
- **Recalling firm:** Oscor Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-10
- **Report date:** 2026-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Palm Harbor, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2679-2026

## Citation

> MORVS. FDA recall Z-2679-2026. Retrieved 2026-10-22 from https://api.morvs.ai/recall/Z-2679-2026. Source: US FDA. Licensed CC0.

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