Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Take action
Contact the company
📍Recalling firmCardinal Health 200, LLC15 Hampshire St Bldg 5 · Mansfield, MA 02048-1113
“Cardinal Health Monoject Needles: Non-sterile Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65998-cardinal-health-monoject-needles-non-sterile-risk. Based on FDA recall #Z-1454-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1454-2020%22&limit=1).
Cardinal Health 200, LLC recalled Monoject Hypodermic Safety Needles because the product was non-sterile despite packaging labeled "STERILE" and "NON-STERILR," according to the FDA on Jan. 15, 2020. The agency said the hazard could result in infection.
How to tell if you have it
Brand: Cardinal Health
Product: Monoject Hypodermic Safety Needle 30G X 1/2"
Item Code: 1183005
Lot No.: 15063001
Expiration Date: 05/31/2020
The hazard
The product did not undergo the sterilization process and was shipped to customers as non-sterile. The usage of a needle that is not sterile could result in infection. The firm is not aware of any reports of patient harm.
Context
GovInfoNow's records show Cardinal Health 200, LLC has had 59 other recalls on record since June 27, 2017. Other recent recalls of similar products include Presource Convenience Kits Recall: Contaminated Applicators Risk Infection (Aug. 10, 2026), Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (Jan. 7, 2026), and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026).
How to tell if you have this one
Check for item code 1183005 on the needle packaging. The needles expire May 31, 2020, and were shipped with a label showing both "STERILE" and "NON-STERILR".
Brand
Cardinal Health
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distributions - US Nationwide distributions in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and countries of Canada, Australia, South Africa, Belgium, Germany, Ireland, Portugal Spain, and UK.
Recall number
Product, codes & lots
Quantity
Z-1453-2020
Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.; Lot No. 15072015, Item Code 11832215 , Expires 06/20/2020.
8400 each
Z-1454-2020
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.; Lot No. 15063001, Item Code 1183005, Expires 05/31/2020
8000
Z-1455-2020
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.; Lot No. 15063004, Item Code 1182558, Expires 5/31/2020
—
Z-1456-2020
Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.; Lot No. 15072024, Item Code 11811022F, Expires 06/20/2020
8000
Based on the official FDA remedy
What to do — step by step
Check Needle Label
Look for item code 1183005 and expiration date May 31, 2020 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 47 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distributions - US Nationwide distributions in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-1454-2020 (January 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1454-2020 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.