Ligamax 5 mm Endoscopic Clip Applier Recalled for Sterility Breach Risk
Ethicon Endo-Surgery Inc is recalling Ligamax 5 mm Endoscopic Multiple Clip Appliers due to potential holes in the Tyvek lidding that could breach sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential breach of sterility in a medical device, which poses a risk of harm without reported injuries, fitting the 'High' severity criteria.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 48,428 units of the Ligamax 5 mm Endoscopic Multiple Clip Applier. The recall involves specific product code 11EL5ML and a list of 32 lot numbers, including T93X4R, T93X9D, and T94H78.
The recall was initiated because a potential exists that certain devices within the impacted lots may have small holes in the Tyvek lidding. This defect could result in a breach of sterility for the medical device.
The affected products were distributed nationwide in the United States and internationally to numerous countries, including Argentina, Australia, Canada, China, France, Germany, India, Japan, Mexico, and the United Kingdom. Users of these devices should check their inventory against the provided lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- Ligamax 5 mm Endoscopic Multiple Clip Applier
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 48,428
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 (20)
- Product Code: 11EL5ML Lot Numbers: T93X4R
- T93X9D
- T93Y2Z
- T93Y70
- T93Y96
- T93Z52
- T93Z76
- T9401C
- T9408F
- T94118
- T9416M
- T9422K
- T9426Z
- T94402
- T94536
- T94567
- T9461M
- T94667
- T94721
- T94758
Distribution
Distributed nationwide across the United States.
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