Lower riskMedical device recall · FDA · Published August 4, 2021
Cardinal Health Monoject Syringe Recall: Air Reintroduction Risk
Cardinal Health recalls Monoject 0.9% Sodium Chloride Flush Syringes due to potential air reintroduction after expelling air. Affected units have specific product codes and were sold in certain regions.
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Take action
Contact the company
📍Recalling firmCardinal Health777 West St · Mansfield, MA 02048-1122
✎ GovInfoNow plain-language explainer
Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes with a specific product code because the plunger might draw air back into the syringe after expelling air. This could lead to air being reintroduced into the IV system, potentially causing issues during medical procedures. Read more at govinfonow.com/recall/62081-cardinal-health-monoject-syringe-recall-air-reintroduction-risk.
“Cardinal Health Monoject Syringe Recall: Air Reintroduction Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62081-cardinal-health-monoject-syringe-recall-air-reintroduction-risk. Based on FDA recall #Z-2286-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2286-2021%22&limit=1).
Cardinal Health recalled Monoject 0.9% Sodium Chloride Flush Syringes due to a potential plunger hazard that may reintroduce air into the syringe, according to the FDA on Aug. 4, 2021.
Lot Codes: 20D0614, 21D0894, 20D0624, 20D0674, 20D0684, 20H1504, 20H1514
Distribution: US Nationwide
The hazard
The plunger may draw back after air has been expelled and reintroduce air back into the syringe.
Context
GovInfoNow's records show Cardinal Health has 4 other recalls on record since 2013-10-02. Other recent recalls include the Cardinal Health Dover Closed Uthral Tray Recall (2022-11-01), the Cardinal Health SmartGown Surgical Gowns Recall (2021-11-02), and the Cardinal Health AAMI 3 Gowns Recall (2020-01-11). Other recent recalls of similar products include the Cardinal Health Monoject Tuberculin Syringe Recall (2026-02-27) and B Braun Medical IV Set Recalls (2025-10-29).
How to tell if you have this one
Check for product code 8881570125 on the syringe. The syringe is labeled as Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE.
Brand
Cardinal Health
Category
Medical device
FDA recall event · 3 products
All 3 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 I
Status
Ongoing
Distribution
US Nationwide Distribution: 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, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.; 20I1524 20D0694 20I1584
Z-2286-2021
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.; 20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514
Based on the official FDA remedy
What to do — step by step
Check Product Code
Look for product code 8881570125 on the syringe label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 49 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution: 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, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.” 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, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 28 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 recall indicates a potential risk of air reintroduction, but the hazard is low risk. Healthcare professionals should follow the recall instructions.
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-2286-2021 (August 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2286-2021 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.