FDA Recalls Covidien Endo GIA AutoSuture Universal Loading Units
FDA is recalling 6,751 units of the Covidien Endo GIA AutoSuture Universal Loading Unit because a defect may cause difficulty firing the device, potentially requiring medical intervention.
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 agency classifies this as an FDA Class II recall involving a medical device defect that may require medical intervention, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 6,751 units of the Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm (Product Code: 030450). The device is used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. The recall affects specific lot codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
The recall was initiated because the single-use loading unit contained two staples loaded in each cartridge pocket. This defect may result in difficulty firing the device and removing it from the application site, which may require medical intervention. The agency classifies this recall as Class II.
The affected products were distributed worldwide, including in the USA, Asia Pacific, Canada, Europe, and Japan. Healthcare providers and facilities should stop using the affected units and contact the recalling firm, Covidien LP, for further instructions.
The recalled product
- Product
- Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
- Manufacturer
- Covidien LP
- Affected units
- 6,751
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 (4)
- Lot Codes: N2F0563LX
- N2F0341LX
- N2F0725LX
- and N2E0605LX.
Distribution
Distribution scope not specified by the agency.
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