Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the defect may lead to bleeding or leakage of luminal contents, which constitutes a significant injury risk.
Plain-English summary
Medtronic is recalling 169,775 units of Endo GIA universal and Endo GIA universal XL staplers. The recall was initiated because the device may be missing a sled component, which is responsible for staple deployment.
The missing component may result in the failure to form a staple line when tissue is divided during surgery. This malfunction could lead to bleeding or the leakage of luminal contents. The affected lots are identified by the code 0215122344.
These devices were distributed worldwide and across the United States. Healthcare providers and facilities should check their inventory for the affected lot number and stop using these devices if the sled component is missing or if the lot matches the recall criteria.
The recalled product
- Product
- BOX VWR ZESTAW DO VATS KLIN 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…
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 169,775
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots:0215122344
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by COVIDIEN MEDTRONIC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 40 products in this recall →Related recalls
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