Linear cutter reloads recalled after devices were shipped unsterilized
Ethicon Endo-Surgery is recalling three ECHELON LINEAR Cutter Reload 80 mm Blue units because the devices were shipped unsterilized.
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: Scored 3 under the risk-of-harm criterion: an unsterilized surgical device creates an infection risk, and no injuries are reported.
Plain-English summary
ECHELON LINEAR Cutters Reload 80 mm Blue, product number GLC80, intended for transection, resection and/or creation of anastomoses, are being recalled.
The devices were shipped unsterilized.
The recall covers three units carrying UDI-DI 10705036030881, lot 904C12. Distribution was international, to the United Arab Emirates. The FDA has classified the action as Class II.
Because the reload is used inside the body during surgery, any unit from the affected lot should be treated as non-sterile regardless of its packaging, quarantined, and handled per Ethicon's instructions.
The recalled product
- Product
- ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 3
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 (2)
- UDI-DI: 10705036030881
- Lot Number: 904C12
Distribution
Distribution scope not specified by the agency.
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