# FDA recall Z-1551-2026

> **Boston Scientific Corporation** · Class II · device recall initiated 2026-02-10.

## Product

EndoVive Safety PEG Kit;  Outer Box Material Number (UPN): M00509001;  Inner Box Material Number (UPN): M00509000;

## Reason for recall

Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit  components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1551-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-10
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1551-2026

## Citation

> AI Analytics. FDA recall Z-1551-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-1551-2026. Source: US FDA. Licensed CC0.

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