Covidien ROTICULATOR 30-4 — Class II medical device recall Z-1847-2012
Terminated recall by Covidien LP, reported 2012-06-27, distributed nationwide. Potential for the sterility barrier to be compromised.
| Recall number | Z-1847-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP, North Haven, CT, United States |
| Recall initiated | 2012-05-09 |
| Classified | 2012-06-20 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2014-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CN, CR, CZ, DE, ES, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IN, IT, JP, KR, LK, MX, MY, PE, PT, TH, TW |
| Quantity | 28,248 units |
| Reason classes | sterility |
| Model numbers | 017617, OOB0117, OOBOI22, OOZ0800, OOZ0976, OOZ1401, OOZ1407 |
Product
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Reason for recall
Potential for the sterility barrier to be compromised.
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-1847-2012. 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.