Starling Monitor Devices Recalled for Incorrect Device Identification Labeling
Baxter Healthcare is recalling Starling Monitor devices and accessories due to incorrect Unique Device Identification (UDI) information on labels and non-compliant barcodes. Approximately 9,671 units distributed nationwide are affected.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving incorrect labeling and barcode compliance issues with no reported injuries or illnesses. The hazard is a documentation and identification problem rather than a direct clinical safety risk, consistent with FDA Class III recalls being typically scored 1 or 2.
Plain-English summary
Baxter Healthcare Corporation is recalling Starling Monitor devices (product codes CMMST5 and CMM-ST5), along with the Starling Battery Pack and Starling Patient Cable accessories, due to labeling defects affecting device identification and tracking.
The recalled devices have incorrect or incomplete Unique Device Identification (UDI) information printed on their labels, and the barcodes do not comply with GS1 standards. This labeling issue affects approximately 9,671 units with serial numbers after June 2016 that were distributed nationwide and to government and military facilities.
The incorrect UDI information prevents proper electronic identification and tracking of the devices in healthcare systems. Healthcare providers and facilities that have received these devices should contact Baxter Healthcare Corporation for instructions on obtaining corrected labeling or replacement units.
The recalled product
- 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.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 9,671
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- correct UDI-DI: 07290013030054.
Distribution
Distributed nationwide across the United States.
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