Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals
Aomori Olympus is recalling biliary stents because inspection found some sterile packages had inadequate seals, posing a risk of infection if non-sterile equipment is 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 involves a risk of infection from non-sterile equipment, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the PBD-203-0704 Biliary Stent, model no. PBD-203-0704. This medical device is used with endoscopes for endoscopic retrograde biliary drainage. The recall involves 260,395 units in the United States, with a total of 7,400,000 units affected globally.
The recall was initiated after inspection confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment presents a risk that patients may develop infections.
The affected products were distributed nationwide in the United States. Healthcare providers and facilities should stop using the affected biliary stents and contact the recalling firm for further instructions on how to handle the devices.
The recalled product
- Product
- PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
- Manufacturer
- Aomori Olympus Co., Ltd.
- Category
- Medical Device — Biliary Stent
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 (1)
- 04K
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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