Recall of BD Pyxis CII Safe ES devices with software version 1116-00 due to risk of dispensing incorrect medications, potentially causing medication errors or stockouts. Affected units include specific serial numbers.
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
Take action
Contact the company
📍Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
✎ GovInfoNow plain-language explainer
CareFusion recalls BD Pyxis CII Safe ES automated dispensing cabinets with software version 1116-00 because a software issue may cause the device to dispense the wrong medication or refill incorrect medication pockets. This could lead to medication errors or stockouts if the wrong medication is used. Read more at govinfonow.com/recall/53491-bd-pyxis-cii-safe-es-software-issue-wrong-medication-dispensing.
“BD Pyxis CII Safe ES Software Issue: Wrong Medication Dispensing Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53491-bd-pyxis-cii-safe-es-software-issue-wrong-medication-dispensing. Based on FDA recall #Z-0672-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0672-2025%22&limit=1).
The FDA announced on Nov. 14, 2024, that CareFusion 303, Inc. is recalling BD Pyxis CII Safe ES automated dispensing cabinets due to a software issue that may cause the wrong medication to be dispensed. Owners should contact the company for a remedy.
How to tell if you have it
BD Pyxis CII Safe ES
REF: 1116-00
The hazard
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position. This can lead to unintended and incorrect medication removal or potential for a different medication to be refilled or loaded, which may lead to low inventory or a stockout.
Context
GovInfoNow's records show CareFusion 303, Inc. has 64 other recalls on record since 2017-06-12. Other recent recalls of similar products include BD Pyxis ES Enterprise Server Software Update Issue Recall (2025-12-03), Fresenius Medical Care 5008X CAREsystem Recall (2025-10-25), and Baxter Novum IQ Syringe Pump Recall (2026-08-11).
How to tell if you have this one
Check if your device has the software version labeled as 1116-00. The device model is BD Pyxis CII Safe ES. Affected units include specific serial numbers listed in the recall notice.
Brand
BD Pyxis
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 II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.
Verify your device's software version is 1116-00 by checking the device label or documentation.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT,…” 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-0672-2025 (November 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0672-2025 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.