FDA Recalls Multifire Endo Hernia Staplers Due to Assembly Error
The FDA is recalling 12,610 Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly.
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 rubric specifies that FDA Class II recalls with potential for significant injury or structural defects in medical devices are rated as Severe (4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 12,610 units of the Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit, Part No. 174027. The product is manufactured by Covidien Llc and was distributed worldwide. The recall affects specific lots: P9J0368Y, P9J0369Y, P9J0517Y, and P9K1300Y.
The recall is due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed. This product is used in endoscopic general surgery procedures for the fixation of mesh in the repair of hernial defects and in other surgical specialties for the approximation of tissues.
Healthcare providers and facilities should check their inventory for the affected part number and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or the designated recall coordinator as instructed by the FDA.
The recalled product
- Product
- Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of…
- Manufacturer
- Covidien Llc
- Affected units
- 12,610
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 P9J0368Y P9J0369Y P9J0517Y P9K1300Y
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Covidien Llc 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.
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