Aomori Olympus Recalls ForceMax Lower Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax Lower injectors because some sterile packages have inadequate seals, posing an infection risk if 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 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 INJECTOR FORCEMAX LOWER 23G 6MM 5/BX (model no. NM-400U-0623) medical devices. These injectors are 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 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 in these procedures may result in patients developing infections.
The affected units were distributed nationwide in the United States. The recall covers specific lot codes including 01K through 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V through 09V, and 0XV. Healthcare providers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - 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 (20)
- 01K
- 02K
- 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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