FDA Device recall Z-1820-2018
Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) Product Usage: The Endo GIA universal and Endo…
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) Product Usage: The Endo GIA universal and Endo… by Covidien Medtronic, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1820-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-26 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien Medtronic |
| Distribution | US |
Product
Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) 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
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.
Identifiers
| code_info | Lots: N7L0911KX, N7M0067KX, N7F0631KX, N7L0465KX, N7L0117KX, N7L0768KX, N7M0314KX,N7M0314KX,N7L1075KX, N7M0646KX, N7M07…Lots: N7L0911KX, N7M0067KX, N7F0631KX, N7L0465KX, N7L0117KX, N7L0768KX, N7M0314KX,N7M0314KX,N7L1075KX, N7M0646KX, N7M0740KX, N7M0972KX, N8A0172KX, N8A0539KX, N8A0679KX, N8A0910KX, N8A0961KX, N8B0054KX, N8B0099KX, N8C0008KX, N8C0205KX, N8C0532KX, N8C0571KX, N8C0758KX, N8C0795KX, N8C1284KRX GTIN # 1 (Inner Carton) - 10884523002898 GTIN # 2 (Outer Carton)- 20884523002895 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1820-2018%22
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