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RecallWatchMedical Device Safety
Class IIOngoingZ-1645-2026

CareFusion 303, Inc. recalls BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

CareFusion 303, Inc.San Diego, CA, United StatesReported Apr 1, 2026 · 3 months ago
Legal News Analyst ·

Reason for recall

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
    UDI-DI codesCatalog # Number
    400 affected lots
    1236096812360983123609851236098612360987123609881236098912360990
    +392 more1236099112360992123609931236099412360995123609961236099712360998123609991236100012361001123610021236100312361004123610051236100612361008123610101236101312361017123610181236101912361020123610211236102212361024123610261236102712361028123610291236103012361031123834701238347112383472123868841238688512388269123896531238966012389680123896831238969112389698123897151238972712389730123897341238973812389740123897411239006112390104123901071239011812390133123901551239018412390187123901991239021912390236123902391239025712390258123902711239027412390290123902931239030012390301123903021239055812390560123905781239059712390603123906191239062012390634123906351239065412390662123906661239067012390678123907011239072112390722123907291239073112390736123907381239383312393834123938361239384312393870123939161239392212393929123939531239395412394011123940121239401312394015123940401239406612394105123941061239412612394171123941791239420912394219123942221239428312394284123942901239429312394298123943011239459612394619123946431239464612394659123946721239467312394716123947451239474612394748123947801239478112394782123947831239484412394848123948491239487112394882123949121239492012394924123949251239492912394932123949371239520612395235123952361239523712395267123952681239530312395304123953051239530912395310123953361239538312395424123954321239543312395455123954571239545812395462123954741239547912395492123955071239550912395524123955461239583612395849123958561239587712395928123959331239593812395957123959711239597212395978123959831239598612395997123960411239604912396050123960511239605212396058123960701239607112396091123960991239610312396104123961051239610612396318123963341239633712396338123964581239645912396460123964611239646212396494123964951239649612396497123964981239651512396516123965171239651812396520123966191239662012396622123966231239662412396704123967051239670612396707123967631239676712396771123970391239704012397041123970421239706112397063123970771239708012397087123970881239711712397129123971381239714712397171123971771239718012397192123971951239720712397217123972181239727512397276123972821239729012397293123973071239735612397374123973751239737612397377123973781239737912397380123974031239741212397418123974201239742112397423123974261239742712397430123976801239768112397689123976901239769112397692123977261239772712397806123978071239780812397826123978271239782912397830123978331239783412397835123978481239786312397866123981351239877212404358124043591240458312404584124045861240458712404588124045951240459712404603124046051240460612404607124046081240460912404610124047891240479612404801124048021240480312404804124048631240486412404886124048871240488812404895124048971240489812404899124049001240490612404907124049081240492712404928124049301240493112404945124049531240495412404955124049771240497812404979124049801240498212404983124049961240500212405013124050191240502012405219124052201240522312405224124052311240533112405332124053371240533912405341124055131240551412405515124078881241832212418323124183241241832512418326124183321241833812418345124183521241835312418354124183601241837612418377124183781241837912418385124183861241838712418388

What the firm is doing

On 02/11/2026, the firm sent via US Postal mail, an "URGENT MEDICAL DEVICE PRODUCT CORRECTION" letter to customers informing them that labeling does not indicate which Transport Layer Security (TLS) versions must be enabled on the hospital network to ensure secure Wi-Fi communication with the Alaris and BD Alaris Point-of-Care Unit (PCU) when using enterprise-level Wi-Fi security. Without clear labeling, hospitals may unknowingly disable TLS 1.0, resulting in network connectivity failure and memory leaks which could lead to potential System Error. Customers/clinicians are instructed to: 1. Ensure the PCU is connected to the hospital network by viewing the wireless indicator icon on the front of the PCU. If the icon is illuminated or blinking, the PCU is connected. If it is not illuminated, the PCU is not connected. 2. If icon is not illuminated, follow established hospital protocols for wireless network downtime. 3. If a network connectivity failure persists, System Error may occur on the PCU. This error is indicated by a high priority alarm and red blinking arrow above the SYSTEM ON button. The customer must power down the PCU, then power on again. Any infusion that was ongoing at the time of System Error must be reprogrammed. 4. If using enterprise-level network security, customers/IT Security should be aware of which versions of TLS must be enabled to ensure connectivity. Refer to Appendix A for additional network administration guidance and compatibility. 5. Disseminate and post this notice within their facility to ensure that all concerned personnel, including IT and network connectivity owners or administrators, are notified and aware of this issue. For Questions/Assistance - contact the Recall Support Center at: Phone: 1-888-562-6018 Phone Hours: 7:00am to 4:00pm PT, Monday- Friday Email: SupportCenter@bd.com

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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CareFusion 303, Inc. recalls BD Alaris" System with Guardrails" Suite MX with Point of Care Unit · RecallWatch