# FDA recall Z-0591-2026

> **Draeger, Inc.** · Class I · device recall initiated 2025-11-10.

## Product

ErgoStar CM 45,   Model/Catalog Number: MP01845,      Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

## Reason for recall

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

## Distribution

Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.

## Key facts

- **Recall number:** Z-0591-2026
- **Recalling firm:** Draeger, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-10
- **Report date:** 2025-12-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Telford, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2026

## Citation

> AI Analytics. FDA recall Z-0591-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0591-2026. Source: US FDA. Licensed CC0.

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