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.
What this means for you
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 sy
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Insulin Syringe
- 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
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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