PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01… — Class II medical device recall Z-0695-2019
Terminated recall by Ethicon Endo-Surgery Inc, reported 2019-01-16, distributed nationwide. Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or
| Recall number | Z-0695-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2018-12-07 |
| Classified | 2019-01-08 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2020-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, BR, CA, CL, CN, CO, CR, EC, EG, ID, IN, JP, KR, KW, LB, MX, NI, PK, SA, SG, TW, UY, VN |
| Quantity | 480 units |
| Lot numbers | P9461W, P94K20 |
Product
PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler 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
Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
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-0695-2019. 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.