Aomori Olympus Biliary Stent Recalled for Inadequate Package Seals
Aomori Olympus is recalling biliary stents because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
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 is classified as FDA Class II and involves a risk of infection from non-sterile equipment, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the PBD-203-0707 Biliary Stent, a medical device used with endoscopes for endoscopic retrograde biliary drainage. The recall involves 260,395 units distributed in the United States, with lot codes 95K, 96K, 97K, 98K, and 99K.
Inspection confirmed that a small percentage of the sterile packages have inadequate package seals, specifically partial heat seals. The FDA classifies this as a Class II recall. The hazard is that patients may develop infections if non-sterile equipment is used due to the compromised sterility of the device.
Healthcare providers and facilities should stop using the affected biliary stents and contact Aomori Olympus for instructions on return or replacement. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -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 (5)
- 95K
- 96K
- 97K
- 98K
- 99K
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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