Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles
Smiths Medical is recalling 108,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.
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 medical device with a visible defect (particulate) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 108,000 units of Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringes. The affected products are 1.0ml, 29g x 1/2 inch syringes, distributed by Cardinal Health in Dublin, OH. The recall is due to visible orange or brown particulate found on the needles.
The affected lot numbers are 2356156 and 2358706. These syringes were distributed nationwide in the United States, including in Arizona, California, Florida, Illinois, Louisiana, Missouri, Mississippi, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin, and West Virginia. They were also distributed in Canada, Italy, and Spain.
Consumers should stop using the affected syringes and contact Smiths Medical or their healthcare provider for instructions on how to return the product.
The recalled product
- Product
- Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single…
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Syringes
- Affected units
- 108,000
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: 2356156
- 2358706
Distribution
Part of a larger recall action
This product is one of 5 recalled by Smiths Medical ASD, Inc. 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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