Agency classClass IIOur severity:High FDA (Devices)·Z-0644-2014·Announced 2014-01-15

Smiths Medical Recalls Insulin Syringes With Visible Particulate on Needles

Smiths Medical is recalling 29-gauge insulin syringes due to visible orange or brown particulate on the needles. The recall covers 506,925 units distributed in the US, Canada, Italy, and Spain.

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 high-risk medical device (insulin syringe) with a physical defect (particulate) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, 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 506,925 units of Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringes, 0.5ml 29g x 1/2 in (Reference: 4429-5). The recall is due to the presence of visible orange or brown particulate on the needles. The affected lot numbers are 2330832, 2336493, 2348708, 2353094, and 2357319.

These sterile, latex-free, single-use devices are intended for the injection of U-100 insulin only. The syringes feature an integral rotational needle protection sheath. The affected units 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 and healthcare providers should stop using the affected syringes and contact Smiths Medical ASD, Inc. for further instructions or a replacement. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The…
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Insulin Syringe
Hazard: foreign-object
injection-hazard
Affected units: 506,925

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 (5)

Lot Numbers: 2330832
2336493
2348708
2353094
2357319

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

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.

See all 5 products in this recall →

Same manufacturer · Smiths Medical ASD, Inc.

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