Terumo 30G Needle Recall Due to Potential Sterility Compromise
Terumo Medical Corporation is recalling 81,000 30G needles due to a potential loss of package integrity 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, but the source text describes a potential loss of package integrity without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Terumo Medical Corporation is recalling 81,000 units of Terumo Needle, 30G x 1/2", Product Code NN3013R. The recall is due to a potential loss of package integrity that may compromise the sterility of the product.
The affected products, identified by Lot Number 181005C, were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.
Consumers and healthcare providers should stop using the recalled needles and contact Terumo Medical Corporation for further instructions or a replacement.
The recalled product
- Product
- Terumo Needle, 30G x 1/2", Product Code NN3013R
- Manufacturer
- Terumo Medical Corporation
- Category
- Medical Device — Needles
- Affected units
- 81,000
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 Numbers 181005C
Distribution
Part of a larger recall action
This product is one of 9 recalled by Terumo Medical Corporation 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.
See all 9 products in this recall →Related recalls
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