BD Alaris" System with Guardrails" Suite MX with Point of Care Unit — Class II medical device recall Z-1645-2026
Ongoing recall by CareFusion 303, Inc., reported 2026-04-01, distributed nationwide. Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on ho
| Recall number | Z-1645-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2026-02-11 |
| Classified | 2026-03-26 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BH, CA, CH, CN, DE, GB, IL, IN, IT, JP, KR, KW, MX, MY, NL, NZ, PH, PK, QA, SA, SG, TR, TW, ZA |
| Quantity | 1,025,567 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 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 and 475 more |
| Model numbers | 8015 |
Product
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1645-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.