Aomori Olympus Recalls B7-2C Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B7-2C Balloon Catheters because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.
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: The recall involves a risk-of-harm product (infection 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 B7-2C Balloon Catheter (13mm dia 2.8). This medical device is used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. The recall affects 260,395 units in the United States, with a global total of 7,400,000 units. The product was distributed nationwide in the US.
The recall was initiated after inspections confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. If non-sterile equipment is used, patients may develop infections.
Healthcare providers and consumers should check their inventory for the affected model number B7-2C and lot codes 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, and 9ZK. Affected units should be removed from use and returned to the manufacturer or an authorized distributor for credit or replacement.
The recalled product
- Product
- B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
- 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 (14)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 98K
- 99K
- 9XK
- 9YK
- 9ZK
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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