(1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX… — Class II medical device recall Z-1849-2018
Terminated recall by COVIDIEN MEDTRONIC, reported 2018-05-23, distributed nationwide. Device may be missing a sled component. The sled component is responsible for staple deployment. This may resu
| Recall number | Z-1849-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN MEDTRONIC, NORTH HAVEN, CT, United States |
| Recall initiated | 2018-04-26 |
| Classified | 2018-07-06 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2020-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 169,775 units |
| Reason classes | packaging |
| Lot numbers | 0214109631, 0214860061, 0214909770, 0214975597, PST01199 |
| Model numbers | PST01199, PST03403 |
Product
(1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403) (3) BOX PST03533 KIT APP STAPLER (Item Number: PST03403) 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1849-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.