Aomori Olympus Recalls 3-Lumen Extraction Balloon V Due to Seal Defects
Aomori Olympus is recalling 3-Lumen Extraction Balloon V devices because some sterile packages have inadequate seals, posing a risk of infection if used.
What this means for you
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 involves a risk of infection from non-sterile equipment, which fits the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the B-V233P-A 3-Lumen Extraction Balloon V, model no. B-V233P-A. This medical device is used with endoscopes to remove stones, such as calculi, pancreatic, and common bile duct stones. The recall affects 260,395 units in the United States, with a global total of 7,400,000 units. The affected products were distributed nationwide in the US and have lot codes 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, and 0XV.
The recall was initiated after inspections confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment can lead to patient infections. The FDA has classified this as a Class II recall.
Healthcare providers and facilities should check their inventory for the specific model and lot codes listed above. If the affected devices are found, they should be removed from use and returned to the manufacturer or disposed of according to the recall instructions provided by Aomori Olympus.
The recalled product
- Product
- B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
- Manufacturer
- Aomori Olympus Co., Ltd.
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 (9)
- 02V
- 03V
- 04V
- 05V
- 06V
- 07V
- 08V
- 09V
- 0XV
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 111 recalled by Aomori 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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