Ethicon Recalls PROXIMATE PPH Hemorrhoidal Circular Staplers Due to Missing Washer
Ethicon Endo-Surgery Inc is recalling 15,264 units of PROXIMATE PPH Hemorrhoidal Circular Staplers because they may be missing a washer, potentially causing bleeding or soft tissue injury during use.
What this means for you
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 source text identifies a risk of harm (bleeding or soft tissue injury) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 15,264 units of the PROXIMATE PPH Hemorrhoidal Circular Stapler (Product Code: PPH03). The device is used throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
The recall was initiated because the staplers 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 units 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. Specific lot codes affected include P93K95, P9420Y, P94A4T, P93L1M, P9420Z, P94D3N, P93M3G, P9441H, P94F3Z, P93T35, P9450L, P94G04, P93T7F, P9463J, P94H5F, P93W3M, P94765, P94J4W, P93W3N, P9487Z, P94J80, P93Y58, P94901, P94K2A, P94117, P94A20, and R9200Z. Healthcare providers should stop using the affected devices and contact Ethicon Endo-Surgery Inc for further instructions.
The recalled product
- Product
- PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 15,264
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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