Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The… — Class I medical device recall Z-0057-2013
Terminated recall by Ethicon Endo-Surgery Inc, reported 2012-10-24, distributed nationwide. Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE¿ PPH Hem
| Recall number | Z-0057-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Cincinnati, OH, United States |
| Recall initiated | 2012-08-03 |
| Classified | 2012-10-12 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2013-07-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BH, BR, CL, CN, CO, CR, CY, DO, EC, EG, GR, GT, HK, ID, IL, IN, IT, JO, JP, KR, KW, LB, MX, MY, NI, NP, PA, PE, PH, PK, PY, RU, SA, SG, SI, SV, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 157,881 devices |
| Lot numbers | 030, 144, 432, 963 |
| Expiration dates | 2016-03-20, 2016-04-20, 2016-09-20 |
Product
Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal tissue. The TRANSTARTM CIRCULAR STAPLER, (STR10), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Reason for recall
Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar¿ Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.
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-0057-2013. 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.