COVIDIEN MEDTRONIC: Medical Device Recall in 2018 - (Recall #: Z-1855-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

(1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04090 BYPASS AIWA CLINIC Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Product Classification:

Class II

Date Initiated: April 26, 2018

Date Posted: May 23, 2018

Recall Number: Z-1855-2018

Event ID: 79974

Reason for Recall:

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

Status: Terminated

Product Quantity: 169,775 units in total

Code Information:

Lot Numbers: (1) 0215237526, 0214991351, 0214991350, 0215157998, 0215157997 (2) 0215237527, 0215282382, 0214991349, 0214991348, 0214991347

Distribution Pattern:

Worldwide and US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated