Aomori Olympus Recalls Endoscopic Injectors Due to Package Seal Defects
Aomori Olympus is recalling endoscopic injectors because 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 from non-sterile equipment) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the INJECTOR FORCEMAX LOWER 25G 6MM (model no. NM-400U-0625). This medical device is used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. The recall affects 260,395 units in the United States, with a total of 7,400,000 units affected globally.
The recall was initiated after inspections confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment presents a risk that patients may develop infections.
The affected units were distributed nationwide in the US. The specific lot codes involved are 01K, 02K, 03K, 05K, 06K, 09K, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, and 0XV. Healthcare providers and consumers should check their inventory for these specific model numbers and lot codes and stop using the affected devices.
The recalled product
- Product
- INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
- 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 (15)
- 01K
- 02K
- 03K
- 05K
- 06K
- 09K
- 98K
- 9XK
- 9YK
- 05V
- 06V
- 07V
- 08V
- 09V
- 0XV
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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