J&J Staple Accessory Kit Recall

Johnson and Johnson has recalled more than 157,000 surgical stapler devices and accessories used in hemorrhoids treatment procedures due to potential malfunctions that pose a serious safety risk. The recall is a Class 1 recall, the most serious classification of recalls. Class 1 recalls are only issued when a defective medical device is likely to cause serious health problems or death. 

These products are commonly referred to as “Staple Accessory Kits” or “Internal Hemorrhoid Staples”. They are manufactured by J&J's Ethicon Endo-Surgery division. 

The recalled products are:

Transtar Circular Stapler Procedure Set

Proximate HCS Hemorrhoidal Circular Stapler and Accessories

Proximate PPH Hemorrhoidal Circular Stapler and Accessories

The FDA issued a recall based on issues related to the firing of the device which may result in incomplete staple formation. An incomplete staple formation is similar to when you attempt to staple too many pieces of paper together and the staple does not puncture through all of the pieces and does not fasten correctly.

Failure of an incomplete staple formation can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, occlusion of the rectal canal, and splitting of rectal wall staple line and bleeding.

The affected products were manufactured and distributed between April 2011 and July 2012.

J&J said its Proximate HCS hemorrhoidal circular stapler and accessories with product code "PPH01" have been discontinued in the U.S. However, the Proximate PPH stapler remains available.

Pittman, Dutton & Hellums, P.C. is currently investigating “Staple Accessory Kit” injury claims. If you or a loved one were injured as a result of this product, please contact Booth Samuels at    1-866-515-8880 or by email at booths@pittmandutton.com.