The Neonatal Flow Sensor Cable used on devices CARESCAPE R860 — Class II medical device recall Z-2738-2018
Terminated recall by Datex-Ohmeda, Inc., reported 2018-08-15, distributed nationwide. The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
| Recall number | Z-2738-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datex-Ohmeda, Inc., Madison, WI, United States |
| Recall initiated | 2018-06-28 |
| Classified | 2018-08-08 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2019-02-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BD, BR, CL, CN, CO, DE, DZ, ES, GR, GT, HN, ID, IN, IQ, IR, IT, KE, LB, MA, MX, MY, NG, NL, NP, PK, PL, RO, RU, SA, SG, TN, TR, VN, ZA |
| Quantity | 417 units |
| Serial numbers | 5461218-1, 5466360-1, 5466360-2, 5466481-1, 5466642-1, 5467664-1, 5467910-1, 5468261-1, 5468261-2, 5468985-1, 5469052-2, 5469462-1, 5469869-1, 5470666-1, 5470881-1, 5471291-1, 5471291-2, 5471316-1, 5471539-1, 5472210-1, 5472270-1, 5472842-1, 5473124-1, 5473192-1, 5473198-1 and 391 more |
| Model numbers | 1505-5604-000, 1506-8600-000, 2080496-010 |
Product
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.
Reason for recall
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
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-2738-2018. 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.