Ethicon Recalls PROXIMATE Skin Staplers Due to Unformed Staple Risk
Ethicon Endo-Surgery Inc is recalling PROXIMATE skin staplers because a non-conforming component may cause the device to fire an unformed staple.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (firing an unformed staple) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling specific models of PROXIMATE skin staplers, including the PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), and their bulk/non-sterile counterparts (Models CK 117 and CK 158). The recall involves 42,798 units distributed worldwide, including nationwide distribution in the United States and in various countries across Europe, Asia, Africa, and the Middle East.
The recall is being conducted because the devices may contain a non-conforming component that could cause the device to fire an unformed staple. These skin staplers are designed for single-patient use to apply rectangular stainless steel staples for routine wound closure.
Healthcare facilities and distributors should check their inventory for the specific batch numbers listed in the recall notice. If the affected devices are found, they should be removed from use and returned to Ethicon Endo-Surgery Inc according to the instructions provided by the manufacturer.
The recalled product
- 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…
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 42,798
Distribution
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