ErgoStar CM 55 — Class I medical device recall Z-0592-2026
Ongoing recall by Draeger, Inc., reported 2025-12-17, distributed in CA, FL, IL, NY, OH, OK, PA, SC…. Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
| Recall number | Z-0592-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger, Inc., Telford, PA, United States |
| Recall initiated | 2025-11-10 |
| Classified | 2025-12-08 |
| Reported by FDA | 2025-12-17 |
| Distributed | CA, FL, IL, NY, OH, OK, PA, SC, TX, WI |
| Countries outside the US | AT, AU, BE, BG, BR, CA, CH, CL, CN, CZ, DE, EC, ES, FI, FR, GB, HU, ID, IT, JP, KR, MX, NL, NO, PK, PL, PT, RO, RS, SA, SK, TH, UA, ZA |
| Quantity | 118,850 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04048675420705 |
| Model numbers | MP01855 |
Product
ErgoStar CM 55, Model/Catalog Number: MP01855, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0592-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.