FDA Device recall Z-2610-2014
PROXIMATE Skin Stapler
- FDA Device
- Class II
- terminated
- Published 2014-09-17
On 2014-09-17 the FDA classified a Class II recall of PROXIMATE Skin Stapler by Ethicon Endo Surgery, citing the device may have a non-conforming component that may cause the device to fire an unformed staple.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2610-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-12 |
| Published | 2014-09-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
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
The device may have a non-conforming component that may cause the device to fire an unformed staple.
Identifiers
| code_info | PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Batch L4EG3F L4EK3Y L4EP22 L4ER1D L4ER9X L4EU87 PROXIMA…PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Batch L4EG3F L4EK3Y L4EP22 L4ER1D L4ER9X L4EU87 PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35) Batch L4EG2T L4EH20 L4EH85 L4EK50 L4EN58 L4EN94 L4EP2F L4EP6G L4ER1L L4EU0J L4EV07 Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117) Batch L91J4U L91K38 L91K6N L91M8N L91N22 L91W33 L91X5V Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158) Batch L90W40 L90X3C L90Y0U L90Y4V L90Z7C L9108Z L91151 L91223 L91970 L91A7N L91C5C L91E2Z L91E6P L91G46 L91J4L L91K3A L91M4U L91T81 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2610-2014%22
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