Smith Medical JELCO Hypodermic Needle Recall for Incorrect Specifications
Smiths Medical ASD Inc. is recalling JELCO Hypodermic Needles with incorrect length and gauge. The recall covers 109,000 units distributed nationwide.
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 does not report any injuries, illnesses, or hospitalizations. The hazard is a specification error (incorrect length/gauge) without reported harm, fitting the Moderate criteria for low-risk issues or voluntary precautionary actions.
Plain-English summary
Smiths Medical ASD Inc. is recalling JELCO Hypodermic Needles equipped with the Needle-Pro EDGE Safety Device. The recall is due to incorrect needle length and gauge. The affected product is a disposable, single-use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe.
The recall involves 109,000 units, with 96,000 distributed in the United States. The affected items are identified by Item # 402010 and Lot # 3707576. Distribution was nationwide across 20 states, including Arizona, California, Florida, Georgia, Illinois, Indiana, Massachusetts, Minnesota, Missouri, Mississippi, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, and Washington.
Consumers and healthcare providers should stop using the affected needles and contact Smiths Medical ASD Inc. for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle…
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Needles
- 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 (1)
- Item # 402010 Lot # 3707576
Distribution
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