Multifire Endo Hernia Stapler Recalled for Manufacturing Assembly Error
Covidien is recalling Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly during use.
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 source explicitly identifies this as an FDA Class II recall. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving surgical instruments where failure could lead to significant injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit, manufactured by Covidien LLC. The recall affects 12,610 units distributed worldwide, specifically Lots P9J1171Y, P9K1395Y, and P9K1582Y.
The recall was initiated 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 device 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 facilities and users should stop using the affected devices and contact the recalling firm for further instructions. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - 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 P9J1171Y P9K1395Y P9K1582Y
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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