Recall archive / FDA device enforcement
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/... — FDA record Z-1817-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 2, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
- Classification
- Class III
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 9,671 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1817-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All serial numbers after 6/2016. Product code CMMST5 - Incorrect UDI-DI: 7290013030269; correct UDI-DI: 07290013030269. Product code CMM-ST5 - Incorrect UDI-DI: 7290013030030; correct UDI-DI: 07290013030030. Product code CMABATT - Incorrect UDI-DI: 7290013030160; correct UDI-DI: 07290013030160. Product code CMASC10 - Incorrect UDI-DI: 7290013030054; correct UDI-DI: 07290013030054. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide Distribution and government/military distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 5, 2022
- Recall initiation date
- Sep 2, 2022
- Center classification date
- Sep 26, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.