Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical… — Class II medical device recall Z-1131-2018
Terminated recall by CooperSurgical, Inc., reported 2018-03-28, distributed nationwide. The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
| Recall number | Z-1131-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2017-10-06 |
| Classified | 2018-03-19 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2020-02-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB |
| Quantity | 13 units |
| Reason classes | labeling |
Product
Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.
Reason for recall
The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
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-1131-2018. 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.