# FDA recall Z-0143-2026

> **Boston Scientific Corporation** · Class II · device recall initiated 2025-09-11.

## Product

CXR Preconnect with TENACIO Pump with InhibiZone;  UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);

## Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-0143-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-11
- **Report date:** 2025-10-22

- **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-0143-2026

## Citation

> AI Analytics. FDA recall Z-0143-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0143-2026. Source: US FDA. Licensed CC0.

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