Terumo 18G Needles Recalled for Potential Loss of Package Integrity
Terumo Medical Corporation is recalling 810,000 18G 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Terumo Medical Corporation is recalling 810,000 units of Terumo Needle, 18G x 1", Product Code NN1825R. The recall affects Lot Numbers 180714C and 180723C.
The recall was initiated because there is a potential for a loss of package integrity that may compromise the sterility of the product. The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.
Healthcare providers and consumers should stop using the affected needles and contact Terumo Medical Corporation for further instructions.
The recalled product
- Product
- Terumo Needle, 18G x 1", Product Code NN1825R
- Manufacturer
- Terumo Medical Corporation
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 810,000
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 (2)
- Lot Numbers 180714C
- 180723C
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.
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