Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seal
Aomori Olympus is recalling ForceMax Up injectors 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that patients may develop infections if non-sterile equipment is used. Infection is a significant injury report, which aligns with the 'Severe' criteria for significant injury reports or FDA Class II recalls with potential for serious harm.
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 was initiated after inspection confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment due to these compromised seals may result in patients developing infections.
Approximately 260,395 units were distributed in the United States, with a global total of 7,400,000 units. The affected units were distributed nationwide in the US. Healthcare providers and facilities should check their inventory for the specific lot codes listed in the recall notice and stop using any affected units.
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 (12)
- 01K
- 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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