Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, which could allow non-sterile equipment to be used and cause infection.
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 and involves a risk of infection from non-sterile equipment, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM (model no. NM-400L-0621). 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 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 inspections confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment presents a risk that patients may develop infections.
Healthcare providers and facilities should check their inventory for the affected model and lot codes (01K, 02K, 03K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV) and stop using any units with compromised packaging. Patients who have already received treatment with these devices should contact their healthcare provider if they experience signs of infection.
The recalled product
- Product
- INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - 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 (18)
- 01K
- 02K
- 03K
- 07K
- 08K
- 09K
- 0XK
- 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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