Aomori Olympus Biliary Stent Recalled for 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 is classified as FDA Class II. The hazard 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-203-0703 Biliary Stent, model no. PBD-203-0703. This medical device is used with endoscopes for endoscopic retrograde biliary drainage. The recall involves 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 inspection confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The source text states that patients may develop infections if non-sterile equipment is used.
Healthcare providers and facilities should check their inventory for the affected product. If the product is found, it should be removed from use and returned to the recalling firm or disposed of according to the firm's instructions. Consumers who have had this device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - 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)
- 97K
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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