# FDA recall Z-0993-2026

> **Cook Incorporated** · Class II · device recall initiated 2025-11-26.

## Product

Flexor Check-Flo Introducers and Sets, Reference Part Numbers:    1) KCFW-9.0-18/38-45-RB-ANL0-HC;   2) KCFW-9.0-18/38-45-RB-ANL1-HC;   3) KCFW-10.0-35-45-RB-HFANL0-HC;   4) KCFW-10.0-35-45-RB-HFANL1-HC;   5) KCFW-12.0-35-45-RB-HFANL0-HC;   6) KCFW-12.0-35-45-RB-HFANL1-HC;   7) KCFW-9.0-35-38.5-RB-RTPS-100;   8) KCFW-10.0-35-RB-RTPS-100;   9) KCFW-9.0-38-55-RB-RAABE;   10) KCFW-9.0-38-70-RB-RAABE;   11) KCFW-9.0-38-80-RB;   12) KCFW-10.0-38-30-RB;   13) KCFW-10.0-38-40-RB;   14) KCFW-10.0-38-80-RB;   15) KCFW-10.0-38-RB;   16) KCFW-12.0-38-40-RB;   17) KCFW-12.0-38-80-RB;   Flexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal t

## Reason for recall

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0993-2026
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-26
- **Report date:** 2025-12-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0993-2026

## Citation

> AI Analytics. FDA recall Z-0993-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0993-2026. Source: US FDA. Licensed CC0.

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