Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Recalled by Ethicon Endo-Surgery Inc Due to The device may have a non-conforming component that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ethicon Endo-Surgery Inc directly.
Affected Products
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.
Quantity: 42,798
Why Was This Recalled?
The device may have a non-conforming component that may cause the device to fire an unformed staple.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery Inc has 54 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report