PROXIMATE Skin Stapler — Class II medical device recall Z-2610-2014
Terminated recall by Ethicon Endo-Surgery Inc, reported 2014-09-17, distributed nationwide. The device may have a non-conforming component that may cause the device to fire an unformed staple.
| Recall number | Z-2610-2014 |
|---|---|
| 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 | 2014-08-12 |
| Classified | 2014-09-08 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2015-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, DK, FI, FR, GB, IT, JP, KR, NL, NO, RU, SE, SG, TW, ZA |
| Quantity | 42,798 |
| Lot numbers | L4EG2T, L4EG3F, L4EH20, L4EH85, L4EK3Y, L4EK50, L4EN58, L4EN94, L4EP22, L4EP2F, L4EP6G, L4ER1D, L4ER1L, L4ER9X, L4EU0J, L4EU87, L4EV07, L90W40, L90X3C, L90Y0U, L90Y4V, L90Z7C, L9108Z, L91151, L91223, L91970, L91A7N, L91C5C, L91E2Z, L91E6P, L91G46, L91J4L, L91J4U, L91K38, L91K3A, L91K6N, L91M4U, L91M8N, L91N22, L91T81 and 2 more |
| Model numbers | 117, 158, PRR35, PXR35 |
Product
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.
Reason for recall
The device may have a non-conforming component that may cause the device to fire an unformed staple.
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-2610-2014. 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.