FDA recall, , Moderate risk
BD Alaris System with Guardrails Suite MX with Point of Care Unit
The BD Alaris System with Guardrails Suite MX with Point of Care Unit lacks labeling for secure Wi-Fi communication.
Summary by Recall Canary from the FDA notice
What happened
CareFusion 303, Inc. of San Diego, California, began a recall on February 11, 2026, of the BD Alaris System with Guardrails Suite MX with Point of Care Unit because the product labeling does not indicate which Transport Layer Security (TLS) version must be enabled on a hospital network to ensure secure Wi-Fi communication with Point-of-Care Units.
The FDA added the recall to its Enforcement Report on March 26, 2026, and the distribution was nationwide across U.S. states and to foreign countries including Australia, Belgium, Bahrain, Botswana, Canada, China, Cuba, Germany, India, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
Incomplete list: 1,000 of 984,830 UDI-DIs shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- UDI-DI
- 10885403210747
- 10885403210754
- 10885403210891
- 10885403212048
- 10885403222108
- 10885403224614
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Recall details
- Company began the recall
- Sold in
Worldwide distribution: U.S.(Nationwide) to states of: AL, AR, AZ, CA, CO, CT, 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 O.U.S. (foreign) to countries of: Australia, Belgium, Bahrain, Botswana, Canada, China, Cuba, Germany, India, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
- Company
- CareFusion 303, Inc.San Diego, California
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98250
- Recall number
- Z-1645-2026
All recalls from CareFusion 303, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
