GE HealthCare recalls ONE-CUF blood pressure cuffs (models 1-12) due to potential inaccurate blood pressure readings. Affected units include adult, child, and infant sizes with specific model numbers and GTINs. No remedy is provided in the recall notice.
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
GE HealthCare is recalling its CRITIKON ONE-CUF blood pressure cuffs because they may give inaccurate readings. This could lead to incorrect health decisions if used for blood pressure monitoring. The recall covers multiple model sizes for adults, children, and infants.
The blood pressure cuffs may not measure blood pressure accurately, which could lead to incorrect health assessments. Inaccurate readings might cause unnecessary medical concerns or delayed treatment if the user relies on these devices for monitoring.
Owners of GE HealthCare CRITIKON ONE-CUF blood pressure cuffs with model numbers listed in the recall (adult, child, or infant sizes) are affected. Individuals using these cuffs for home blood pressure monitoring are most at risk of inaccurate readings.
Check for model numbers: ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, or similar variants across adult, child, and infant sizes. The cuffs have no serial numbers and come with specific GTIN numbers listed in the recall notice.
Look for model numbers listed in the recall: ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, or other variants across adult, child, and infant sizes.
No, the recall states that blood pressure cuffs in this recall do not have serial numbers.
Affected models include ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, and other variants for adult, child, and infant sizes as listed in the recall notice.
The recall notice states that no remedy is provided; the user must check if they have the affected models.
We’ve drafted a message you can send GE HealthCare to request your refund or repair — edit it as you like.
Subject: Recall Z-2027-2024 — GE HealthCare GE HealthCare Hello, I own a GE HealthCare that is covered by recall Z-2027-2024 from GE HealthCare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
