# FDA recall Z-2774-2026

> **Micro Therapeutics,  Inc.** · Class II · device recall initiated 2026-06-08.

## Product

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027  REF PED2-300-20

## Reason for recall

Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

## Distribution

US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, 	WA.

## Key facts

- **Recall number:** Z-2774-2026
- **Recalling firm:** Micro Therapeutics,  Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-08
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2774-2026

## Citation

> AI Analytics. FDA recall Z-2774-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2774-2026. Source: US FDA. Licensed CC0.

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