CareFusion recalls Alaris PCA Module 8120 infusion pumps with unvalidated syringe labeling. This could lead to incorrect medication delivery. Affected units have specific serial numbers.
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
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Contact the company
📍Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
✎ GovInfoNow plain-language explainer
CareFusion is recalling Alaris PCA Module 8120 patient-controlled analgesia pumps because their compatible syringes have unvalidated labeling. This could cause incorrect medication delivery if used with syringes not properly tested. The recall affects specific serial numbers. Read more at govinfonow.com/recall/57313-carefusion-alaris-pca-module-8120-syringe-labeling-issue.
“CareFusion Alaris PCA Module 8120: Syringe labeling issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57313-carefusion-alaris-pca-module-8120-syringe-labeling-issue. Based on FDA recall #Z-0186-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0186-2024%22&limit=1).
CareFusion 303, Inc. recalled the Alaris PCA Module 8120 infusion pump due to labeling errors containing unvalidated syringe options, according to the FDA on Sept. 15, 2023.
The Alaris PCA Module 8120 Patient Controlled Analgesia infusion pump has compatible syringes labeling that contains syringes which have not been validated.
Context
GovInfoNow's records show CareFusion 303, Inc. has 64 other recalls on record since June 12, 2017. Recent brand recalls include a Feb. 11, 2026 recall regarding TLS version labeling and an April 30, 2026 recall for overheating fingerprint scanners in BD Pyxis MedStation ES REF 323 cabinets. Other recent recalls of similar products include the Aug. 11, 2026 Baxter Novum IQ Syringe Pump Recall for software issues and the April 10, 2026 Medline EYE TRAY-LF Kit Recall for wrong syringes inside.
How to tell if you have this one
Check the serial numbers on your Alaris PCA Module 8120 pump: 10885403516023, 10885403515231, 10885403801549, 10885403515248, 10885403801532, 10885403515224, or 10885403801518.
Brand
CareFusion
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
Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; OUS (foreign): Canada, Germany, Cuba, Italy, Japan, South Korea, Turkey, United Arab Emirates, Australia, Bahrain, Botswana, Kuwait, Mexico, Netherlands, Philippines, Pakistan, Qatar, South Africa, Singapore, Belgium, Israel, India, New Zealand, Malaysia, Taiwan, Switzerland
Alaris PCA Module 8120; All Lots/ UDI-DI: 10885403516023,10885403515231,10885403801549,10885403515248, 10885403801532,10885403515224,10885403801518
86,393 units
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Verify your pump's serial number against the list: 10885403516023, 10885403515231, 10885403801549, 10885403515248, 10885403801532, 10885403515224, 10885403801518.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA,…” 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, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months 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-0186-2024 (September 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0186-2024 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.