Gastroscope Devices Recalled for Inadequate Channel Drying Process
Aizu Olympus recalls 680 gastroscope-EUS devices due to unvalidated channel drying. Water remaining in the channels poses contamination and infection risks.
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: FDA Class II medical device with risk-of-harm to patients. An unvalidated drying process creates potential for contamination and infection in devices used internally in the gastrointestinal tract. No illnesses or injuries have been reported to date, placing this at the High level per criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling 680 gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) devices used for endoscopic surgery within the upper digestive tract. The affected models are GF-UC140P-AL5, GF-UCT180, and GF-UE160-AL5.
The recall stems from an unvalidated air drying process for the scope channels. A small percentage of scopes returned to customers after repair had water remaining in their channels.
Water in the channels creates the potential for contamination that could lead to infection. The affected devices have been distributed worldwide, including throughout the United States.
The recalled product
- Product
- Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Category
- Medical Device — Endoscopy
- Affected units
- 680
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 Numbers: GF-UC140P-AL5 (04953170356322)
- GF-UCT180 (04953170356339)
- GF-UE160-AL5 (04953170356261).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Aizu Olympus Co., Ltd. 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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