Applied Medical Recalls Epix Universal Clip Appliers Due to Loading Defect
Applied Medical Resources Corp is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.
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 Applier kits, including 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 products are distributed nationwide in the United States, specifically in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. The products were also distributed in foreign countries including Austria, Belgium, Denmark, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, and Great Britain.
The specific lot numbers involved in this recall are 1237620 and 1238063. The Epix disposable laparoscopic clip applier is indicated for the ligation of tubular structures or vessels in laparoscopic and general surgical procedures. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- STD KIT GK260, Standard Set 360 Z 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
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 (2)
- Lot #: 1237620
- 1238063
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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