FDAClass IIMay 23, 2018

(1) BOX Lapzd Zestaw DO SG recall

(1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG Product Usage: The Endo GIA universal and Endo GIA universal XL…

Why was (1) BOX Lapzd Zestaw DO SG recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

(1) Lot: 0215082707, 0215176563 (2) Lot numbers: 0214993037,0214793817,0214930628 0214930630, 0215068849, 0215124284, 0215243236, 0214925902 0214925904, 0214925903, (3) Lot Number: 0215120700

Product
(1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG Product Usage: The Endo GIA universal and Endo GIA universal XL…
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total
Distribution
Worldwide and US Nationwide
Recall date
May 23, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls