Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals
Aomori Olympus is recalling biliary stents because inspection found some sterile packages have 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-harm product (infection risk from non-sterile equipment) where the source text does not report specific injuries or illnesses, aligning with the 'High' severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the PBD-203-0710 Biliary Stent, model no. PBD-203-0710. This medical device is used with endoscopes for endoscopic retrograde biliary drainage. The recall affects 260,395 units distributed nationwide in the United States, with 7,400,000 units affected globally. The specific lot codes involved are 01K and 02K.
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.
Healthcare providers and facilities should stop using the affected biliary stents and contact the recalling firm for instructions on how to return or dispose of the product. Patients who have had these stents placed should consult their healthcare provider if they experience signs of infection.
The recalled product
- Product
- PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -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 (2)
- 01K
- 02K
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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