# FDA recall Z-1101-2026

> **ICU Medical Inc.** · Class II · device recall initiated 2025-12-19.

## Product

Portex Spinal Tray, Item No. A3729-24  A3595

## Reason for recall

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

## Distribution

US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH,  OK, TX, WA.

## Key facts

- **Recall number:** Z-1101-2026
- **Recalling firm:** ICU Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-19
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2026

## Citation

> AI Analytics. FDA recall Z-1101-2026. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1101-2026. Source: US FDA. Licensed CC0.

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