Lower riskMedical device recall · FDA · Published May 17, 2021
Smiths Medical Insulin Syringe Recall: Skewed Graduations Risk Inaccurate Dose
Smiths Medical recalls specific insulin syringes with skewed graduation markings that may cause inaccurate insulin doses. Affected models include 1.0mL 28G and 29G syringes with certain lot numbers. Consumers should check their syringes for upward skewing of markings.
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.
Take action
Contact the company
📍Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
“Smiths Medical Insulin Syringe Recall: Skewed Graduations Risk Inaccurate Dose.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62535-smiths-medical-insulin-syringe-recall-skewed-graduations-risk-inaccurate-dose. Based on FDA recall #Z-1798-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1798-2021%22&limit=1).
The FDA announced on May 17, 2021, that Smiths Medical ASD Inc. is recalling specific lots of Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes because graduation markings were skewed approximately 20 degrees upward. The agency classified the Class I recall as voluntary.
According to the FDA, specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe had odd number line graduation markings on the syringe barrel that were skewed approximately 20 degrees upward.
Context
GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Other recent recalls of similar products include the Smiths Medical CADD Solis VIP Infusion Pump Recall for potential thermal damage (April 10, 2025) and false alarm risk (April 10, 2025), as well as the Smiths Medical CADD Solis HSPCA Pump recall for wireless connection alarms risking serious injury (April 10, 2025).
How to tell if you have this one
Check for syringes with 1.0mL capacity, 28G or 29G needles, and a specific reference number (4428-1 or 4429-1). Look for upward skewing of the graduation markings on the barrel.
Brand
Smiths Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Syringe Markings
Inspect the syringe barrel for upward skewing of graduation markings by about 20 degrees.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of UK, Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1798-2021 (May 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1798-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.