Z-1854-2018 Class II Terminated
FDA device recall Z-1854-2018 was initiated by COVIDIEN MEDTRONIC on Apr 26, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 17, 2020). Affected quantity: 169,775 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- Apr 26, 2018
- Termination Date
- Jun 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169,775 units in total
Product Description
BOX PST03699 KIT APP MED ALTERNATIV STAP 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.
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.
Distribution Pattern
Worldwide and US Nationwide
Code Information
Lots: 0215050309, 0215108007, 0215050310, 0215050308, 0215050311, 0215050312, 0215050313, 0215037144,0215037143, 0215108008
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1854-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026