Use cautionMedical device recall · FDA · Published September 25, 2024
Cardinal Health Monoject U-100 Insulin Syringes Incompatible with IV Connectors
Cardinal Health recalls certain Monoject U-100 insulin syringes that may not work with needleless IV connectors. Stop using these syringes for IV push insulin to avoid potential incompatibility issues.
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
Take action
Contact the company
📍Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337
“Cardinal Health Monoject U-100 Insulin Syringes Incompatible with IV Connectors.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53861-cardinal-health-monoject-u-100-insulin-syringes-incompatible-with-iv. Based on FDA recall #Z-0310-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0310-2025%22&limit=1).
Cardinal Health 200, LLC is voluntarily recalling Monoject U-100 1 mL Insulin Syringes due to incompatibility with needleless IV connectors, the FDA said on Sept. 25, 2024. Owners should not use the syringes for IV push insulin administration via needleless connectors.
How to tell if you have it
Brand: Cardinal Health
Product: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
UDI/DI 10192253034783 (EA), Lot Number 221201, exp. 2027-11-30
UDI/DI 20192253034780 (BX), Lot Number 230201, exp. 2028-01-31
UDI/DI 50192253034781 (CS), Lot Number 230202, exp. 2028-02-01
The hazard
Certain lots of the recalled syringes have demonstrated incompatibility with needleless Intravenous (IV) connectors. The FDA classified this as a Class I recall, indicating a high risk of adverse health consequences.
Context
GovInfoNow's records show Cardinal Health 200, LLC has 58 other recalls on record since 2017-06-27. Other recent recalls include Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets (2026-08-18), Presource Convenience Kits (2026-08-10), and Presource Packs with Contaminated Wipes (2026-07-29). Other recent recalls of similar products include Medline EYE TRAY-LF Kit Recall (2026-04-10) and Medline Convenience Kits with Unapproved Syringes (2026-02-27).
How to tell if you have this one
Check the syringe packaging for lot numbers: 221201 (exp. 2027-11-30), 230201 (exp. 2028-01-31), or 230202 (exp. 2028-02-01). The product is sold under the reference number 1188100777.
Brand
Cardinal Health
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Syringe Lot Number
Look for lot numbers 221201, 230201, or 230202 on the syringe packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
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-0310-2025 (September 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0310-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.