AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System… — Class II medical device recall Z-2829-2016
Terminated recall by AirStrip Technologies, Inc., reported 2016-09-21, distributed in AR, LA. Belt clip may become detached causing electronic components to be exposed.
| Recall number | Z-2829-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AirStrip Technologies, Inc., La Jolla, CA, United States |
| Recall initiated | 2016-08-04 |
| Classified | 2016-09-15 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2016-11-30 |
| Distributed | AR, LA |
| Countries outside the US | NL, ZA |
| Quantity | 42 |
| Reason classes | device malfunction |
Product
AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.
Reason for recall
Belt clip may become detached causing electronic components to be exposed.
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-2829-2016. 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.