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 an infection risk.
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 involves a risk-of-harm product (infection risk from non-sterile equipment) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the B-V243Q-A 3-Lumen Extraction Balloon V, a medical device used with endoscopes to remove stones from the pancreatic and common bile ducts. The recall affects 260,395 units distributed in the United States, with a global total of 7,400,000 units. The affected product codes are 03V, 04V, 05V, 06V, 07V, 08V, 09V, and 0XV.
The recall was initiated after inspections confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment presents a risk that patients may develop infections.
Healthcare providers and consumers should stop using the affected devices and contact Aomori Olympus Co., Ltd. for further instructions on how to proceed.
The recalled product
- Product
- B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-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 (8)
- 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.
See all 111 products in this recall →Related recalls
Same manufacturer · Aomori Olympus Co., Ltd.
See all →- HighReusable Endoscopy Distal Attachments Recalled for Excessive DEHP Levels
FDA (Devices) · 2023-09-13
- HighOlympus Distal Attachment Recalled for Phthalate Exceeding Permissible Levels
FDA (Devices) · 2023-09-13
- HighAomori Olympus Recalls KD-612U Electrosurgical Snare Due to Seal Defects
FDA (Devices) · 2021-02-17
- HighAomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
FDA (Devices) · 2021-02-17
- HighAomori Olympus Recalls 22G EZSHOT Aspiration Needles Due to Seal Defects
FDA (Devices) · 2021-02-17
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19