Applied Medical Recalls Epix Universal Clip Appliers Due to Loading Mechanism Defect
Applied Medical Resources Corp is recalling CA500 Epix Universal Clip Appliers due to a potential loading mechanism nonconformance. The recall affects 1,771 units distributed in the U.S. and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or fatalities, and the defect is described as a potential nonconformance rather than a confirmed failure causing harm.
Plain-English summary
Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Appliers, including kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z. The recall is being conducted because of a potential loading mechanism nonconformance in the affected CA500 lot.
The affected product is a disposable laparoscopic clip applier indicated for the ligation of tubular structures or vessels in laparoscopic and general surgical procedures. A total of 1,771 units were distributed. The distribution pattern includes U.S. nationwide distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ, as well as foreign distribution to Austria, Belgium, Denmark, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, and Great Britain.
The specific lot number for the affected product is 1231562. The source text does not provide specific instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
- Manufacturer
- Applied Medical Resources Corp
- Hazard
- Affected units
- 1,771
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 (1)
- Lot #: 1231562
Distribution
Part of a larger recall action
This product is one of 4 recalled by Applied Medical Resources Corp 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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