Applied Medical Resources Recalls Epix Universal Clip Applier Kits
Applied Medical Resources Corp is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.
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 2/5 (Moderate).
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
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 lots are 1238155, 1238402, and 1238845. The product is indicated for the ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
The recall covers distribution in the United States in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. Foreign distribution includes Austria, Belgium, Denmark, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, and Great Britain.
The recalled product
- Product
- STD GK258, AME Standard Kit 44 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 (3)
- Lot #: 1238155
- 1238402
- 1238845
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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