Cooper Surgical Advincula Arch — Class II medical device recall Z-0440-2013
Terminated recall by Cooper Surgical, Inc., reported 2012-12-05, distributed nationwide. Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, caus
| Recall number | Z-0440-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cooper Surgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2012-10-31 |
| Classified | 2012-11-26 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2014-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CZ, DE, ES, FR, GB, IT, JP, KR, NZ, SA, SE, SG, SI, TW |
| Quantity | 1,215 total |
| Model numbers | UMH750 |
Product
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Reason for recall
Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
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-0440-2013. 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.