Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe recallZ-1798-2021 · Smiths Medical ASD Inc. · initiated May 17, 2021
Class I Terminated All recalls posted in June 2021
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
FDA root cause category: Process control
What the company is doing
The firm initiated the recall on May 17, 2021 by email. The firm is seeking the removal of the product down to the consumer level. For assistance ease contact Novasyte using the Email: [email protected] The firm later realized they failed to include lot #40140906 for model #4429-1 and issued a second letter which was dated 5/27/2021 to customers involved in the first notification where this lot was excluded in the letter, as well as to new consignees who received the affected lot.
Recall details
- Recall number
- Z-1798-2021
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- May 17, 2021
- Posted by the FDA
- Jun 10, 2021
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 1,432,200 units
- Product code
- MEG
- FDA submissions
- K063755
- Distribution
- Worldwide distribution - US Nationwide and the countries of UK, Spain.
Product description
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
Code information (models, lots, serial numbers)
a) REF 4428-1, Lot Numbers: 4046543 and 4062235 b) REF 4429-1, Lot Numbers: 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238, 4062242, 4014096
Other devices under the same FDA submission
5 devices cleared under K063755 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Jelco 4429-1Icu Medical, Inc. · SYRINGE, ANTISTICK6 reports
- Jelco 4427-TBIcu Medical, Inc. · SYRINGE, ANTISTICK2 reports
- Jelco 4430-3Icu Medical, Inc. · SYRINGE, ANTISTICK2 reports
- CARDINAL HEALTH ED12905-INIcu Medical, Inc. · SYRINGE, ANTISTICK2 reports
- Jelco 4428-5Icu Medical, Inc. · SYRINGE, ANTISTICK1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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