Class III — Baxter Healthcare Corporation
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. |
| Product | Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10. |
| Quantity | 9,671 units |
| Distribution | US Nationwide Distribution and government/military distribution. |
| Initiated | 2022-09-02 |
| Classified | 2022-09-26 |
| Recall number | Z-1817-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Baxter Healthcare Corporation (Z-1817-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90809/
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