# FDA recall Z-1814-2025

> **SunMed Holdings, LLC** · Class I · device recall initiated 2025-05-01.

## Product

Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

## Reason for recall

Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.

## Distribution

US Nationwide distribution via Medline.

## Key facts

- **Recall number:** Z-1814-2025
- **Recalling firm:** SunMed Holdings, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-01
- **Report date:** 2025-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1814-2025

## Citation

> AI Analytics. FDA recall Z-1814-2025. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-1814-2025. Source: US FDA. Licensed CC0.

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