Ligating devices recalled because the loop may not release as expected
Olympus is recalling 7,803 Single Use Ligating Devices because the ligation loop may fail to release or detach, leaving it unintentionally fixed around patient anatomy.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The Olympus Single Use Ligating Device, model HX-400U-30, used with an Olympus endoscope to deliver a nylon loop snare, is being recalled.
The firm identifies the potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
The recall covers 7,803 units carrying UDI 04953170368615, across all lots which have not expired. The product was distributed across the United States.
The FDA has classified this as a Class I recall, its most serious category, used where there is a reasonable probability of serious injury or death.
Facilities should quarantine affected stock immediately and follow Olympus' instructions.
The recalled product
- Product
- Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 7,803
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 (3)
- Model/Catalog Number: HX-400U-30
- UDI: 04953170368615
- All Lots which have not expired
Distribution
Distribution scope not specified by the agency.
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