FDA Device recall Z-0696-2019
PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories hav…
- FDA Device
- Class II
- terminated
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories hav… by Ethicon Endo Surgery, citing 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 f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0696-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-07 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
Product
PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
Reason
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
Identifiers
| code_info | Lot Codes: P93K95 P9420Y P94A4T P93L1M P9420Z P94D3N P93M3G P9441H P94F3Z P93T35 P9450L P94G04 P93T7F P9…Lot Codes: P93K95 P9420Y P94A4T P93L1M P9420Z P94D3N P93M3G P9441H P94F3Z P93T35 P9450L P94G04 P93T7F P9463J P94H5F P93W3M P94765 P94J4W P93W3N P9487Z P94J80 P93Y58 P94901 P94K2A P94117 P94A20 R9200Z |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0696-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.