Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax Lower 23G 5MM injectors because some sterile packages have inadequate seals, posing an infection risk.
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 injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the INJECTOR FORCEMAX LOWER 23G 5MM (model no. NM-400U-0523) due to a defect in the sterile packaging. The recall covers 260,395 units distributed in the United States and 7,400,000 units globally. The product is used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Inspection confirmed that a small percentage of the sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment in these procedures may result in patients developing infections.
Healthcare providers and facilities should stop using the affected injectors and contact Aomori Olympus for further instructions. The affected lot codes are 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, and 0XV.
The recalled product
- Product
- INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - 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 (19)
- 01K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 98K
- 99K
- 9XK
- 9YK
- 9ZK
- 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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