# FDA recall Z-2181-2025

> **Ambu Inc.** · Class I · device recall initiated 2025-07-09.

## Product

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611000 5 SPUR II Adult Resuscitator, Pop-off open 40 ,w/PEEP Valve 20, Adult, Catalog Number: 524611001 6 SPUR II Adult Resuscitator w/PEEP Valve 20, Adult, Catalog Number: 524611011 7 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611031 8 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611047 9 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611051 10 SPUR II Pediatric Resuscitator w/10 O2 tube & Manometer, Catalog Number: 530200016 11 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog

## Reason for recall

Potential for the manometer port being blocked rendering the manometer non-functional.

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-2181-2025
- **Recalling firm:** Ambu Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-09
- **Report date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbia, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2181-2025

## Citation

> AI Analytics. FDA recall Z-2181-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2181-2025. Source: US FDA. Licensed CC0.

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