Class II U.S. Food and Drug Administration

CareFusion 303, Inc. BD Alaris" System with Guardrails" Suite MX with Point of Care recall: Due to product labeling not indicating which Transport Layer Security (TLS)

Recall published 7 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1645-2026
Published
April 1, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
CareFusion 303, Inc.
Product type
Medical devices
Units affected
1,025,567
Distribution
Nationwide
Made in
United States
Lot / code info
Catalog Number: 8015 UDI-DI codes: 10885403210747 10885403210754 10885403210891 10885403212048 10885403222108 10885403224614 10885403515231 10885403516023 10885403519215 10885403519284 10885403519291 10885403801518 10885403801532 10885403801549 Serial Numbers: 12360968 12360983 12360985 12360986 12360987 12360988 12360989 12360990 12360991 12360992 12360993 12360994 12360995 12360996 12360997 12360998 12360999 12361000 12361001 12361002 12361003 12361004 12361005 12361006 12361008 12361010 12361013 12361017 12361018 12361019 12361020 12361021 12361022 12361024 12361026 12361027 12361028 12361029 12361030 12361031 12383470 12383471 12383472 12386884 12386885 12388269 12389653 12389660 12389680 12389683 12389691 12389698 12389715 12389727 12389730 12389734 12389738 12389740 12389741 12390061 12390104 12390107 12390118 12390133 12390155 12390184 12390187 12390199 12390219 12390236 12390239 12390257 12390258 12390271 12390274 12390290 12390293 12390300 12390301 12390302 12390558 12390560 12390578 12390597 12390603 12390619 12390620 12390634 12390635 12390654 12390662 12390666 12390670 12390678 12390701 12390721 12390722 12390729 12390731 12390736 12390738 12393833 12393834 12393836 12393843 12393870 12393916 12393922 12393929 12393953 12393954 12394011 12394012 12394013 12394015 12394040 12394066 12394105 12394106 12394126 12394171 12394179 12394209 12394219 12394222 12394283 12394284 12394290 12394293 12394298 12394301 12394596 12394619 12394643 12394646 12394659 12394672 12394673 12394716 12394745 12394746 12394748 12394780 12394781 12394782 12394783 12394844 12394848 12394849 12394871 12394882 12394912 12394920 12394924 12394925 12394929 12394932 12394937 12395206 12395235 12395236 12395237 12395267 12395268 12395303 12395304 12395305 12395309 12395310 12395336 12395383 12395424 12395432 12395433 12395455 12395457 12395458 12395462 12395474 12395479 12395492 12395507 12395509 12395524 12395546 12395836 12395849 12395856 12395877 12395928 12395933 12395938 12395957 12395971 12395972 12395978 12395983 12395986 12395997 12396041 12396049 12396050 12396051 12396052 12396058 12396070 12396071 12396091 12396099 12396103 12396104 12396105 12396106 12396318 12396334 12396337 12396338 12396458 12396459 12396460 12396461 12396462 12396494 12396495 12396496 12396497 12396498 12396515 12396516 12396517 12396518 12396520 12396619 12396620 12396622 12396623 12396624 12396704 12396705 12396706 12396707 12396763 12396767 12396771 12397039 12397040 12397041 12397042 12397061 12397063 12397077 12397080 12397087 12397088 12397117 12397129 12397138 12397147 12397171 12397177 12397180 12397192 12397195 12397207 12397217 12397218 12397275 12397276 12397282 12397290 12397293 12397307 12397356 12397374 12397375 12397376 12397377 12397378 12397379 12397380 12397403 12397412 12397418 12397420 12397421 12397423 12397426 12397427 12397430 12397680 12397681 12397689 12397690 12397691 12397692 12397726 12397727 12397806 12397807 12397808 12397826 12397827 12397829 12397830 12397833 12397834 12397835 12397848 12397863 12397866 12398135 12398772 12404358 12404359 12404583 12404584 12404586 12404587 12404588 12404595 12404597 12404603 12404605 12404606 12404607 12404608 12404609 12404610 12404789 12404796 12404801 12404802 12404803 12404804 12404863 12404864 12404886 12404887 12404888 12404895 12404897 12404898 12404899 12404900 12404906 12404907 12404908 12404927 12404928 12404930 12404931 12404945 12404953 12404954 12404955 12404977 12404978 12404979 12404980 12404982 12404983 12404996 12405002 12405013 12405019 12405020 12405219 12405220 12405223 12405224 12405231 12405331 12405332 12405337 12405339 12405341 12405513 12405514 12405515 12407888 12418322 12418323 12418324 12418325 12418326 12418332 12418338 12418345 12418352 12418353 12418354 12418360 12418376 12418377 12418378 12418379 12418385 12418386 12418387 12418388 12418389 12418390 12418396 12418397 12418410 12418412 12418419 12418420 12418429 12418432 12418433 12418436 12418437 12418438 12418439 124…
UPC codes
10885403210747, 10885403210754, 10885403210891, 10885403212048, 10885403222108, 10885403224614, 10885403515231, 10885403516023, 10885403519215, 10885403519284, 10885403519291, 10885403801518, 10885403801532, 10885403801549

Products covered by this recall

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

Check your product

The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10885403210747
  • 10885403210754
  • 10885403210891
  • 10885403212048
  • 10885403222108
  • 10885403224614
  • 10885403515231
  • 10885403516023
  • 10885403519215
  • 10885403519284
  • 10885403519291
  • 10885403801518
  • 10885403801532
  • 10885403801549

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

CareFusion 303, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: CareFusion 303, Inc. — 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was CareFusion 303, Inc. medical devices recalled?

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 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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10885403210747, 10885403210754, 10885403210891. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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