Ethicon Hemorrhoidal Circular Stapler Recalled for Missing Washer
Ethicon Endo-Surgery Inc is recalling 480 units of the PROXIMATE HCS Hemorrhoidal Circular Stapler because some units may lack a washer, potentially causing bleeding or soft tissue injury during use.
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 involves a medical device with a defect that may cause bleeding or soft tissue injury, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 480 units of the PROXIMATE HCS Hemorrhoidal Circular Stapler (Product Code: PPH01). The recall affects specific lot codes P9461W and P94K20. The device is used for the general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
The recall was initiated because the device may have been assembled without a washer. This defect may potentially cause bleeding or soft tissue injury during use, as the device may not fully cut when fired.
The affected products were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Mexico, Nicaragua, Pakistan, Saudi Arabia, Singapore, Taiwan, Uruguay, and Vietnam. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and…
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 480
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Codes: P9461W
- P94K20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ethicon Endo-Surgery Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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