Agency classClass IIOur severity:High FDA (Devices)·Z-0642-2014·Announced 2014-01-15

Smiths Medical Recalls Insulin Syringes Due to Visible Particulate on Needles

Smiths Medical is recalling specific lots of Hypodermic Needle-Pro Fixed Needle Insulin Syringes because visible orange or brown particulate was found 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 physical defect (particulate on needles) that poses a risk of harm to patients, 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 363,015 units of Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringes. The affected product is a 1.0ml 29g x 1/2 in sterile, latex-free, single-use device intended for the injection of U-100 insulin only. The recall covers specific lot numbers: 2340530, 2344163, 2353091, 2357317, and 2377316.

The recall was initiated due to the presence of visible orange or brown particulate on the needles of the 29g syringes. This particulate matter presents a potential risk to patients using the devices for insulin injection.

The affected syringes were distributed worldwide, including nationwide in the United States (specifically in AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV) and in Canada, Italy, and Spain. Consumers and healthcare providers should check their inventory for the listed lot numbers and discontinue use of the affected syringes.

The recalled product

Product: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 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 Syringes
Hazard: foreign-object
injection-hazard
Affected units: 363,015

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: 2340530
2344163
2353091
2357317
2377316

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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