Epimed COUDE Blunt Nerve Block Needle Recall for Sterility Concerns
Epimed International is recalling COUDE Blunt Nerve Block Needles due to a potential seal defect that may compromise sterility.
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 describes a potential defect without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Epimed International is recalling 300 units of COUDE Blunt Nerve Block Needles (0.71mm x 152mm). The recall is issued because of a potential for partially incomplete seals, which could impact the sterility of the product.
The affected product is distributed domestically in AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, and WA, as well as in Canada, the Czech Republic, Germany, and Turkey. The specific lot number is 12608201 and the reference number is 117-2260.
Healthcare providers and consumers should stop using the recalled needles and contact Epimed International for further instructions or a replacement.
The recalled product
- Product
- COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
- Manufacturer
- Epimed International
- Hazard
- Affected units
- 300
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 No. 12608201
- Ref No. 117-2260.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Epimed International 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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