GE HealthCare CRITIKON ONE-CUF Blood Pressure Cuffs: Inaccurate Measurements Risk
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.
Lower-risk recall
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/55418-ge-healthcare-critikon-one-cuf-blood-pressure-cuffs-inaccurate-measurements.
Source Summary by GovInfoNow · govinfonow.com/recall/55418-ge-healthcare-critikon-one-cuf-blood-pressure-cuffs-inaccurate-measurements · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2027-2024
Cite this page
“GE HealthCare CRITIKON ONE-CUF Blood Pressure Cuffs: Inaccurate Measurements Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55418-ge-healthcare-critikon-one-cuf-blood-pressure-cuffs-inaccurate-measurements. Based on FDA recall #Z-2027-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2027-2024%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
GE HealthCare- Product
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET- Category
Medical device
What to do — step by step
Check Model Numbers
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.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 20 states.
FDA distribution: “US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MO, MS, NC, NJ, NM, OH, PA, TN, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2027-2024 (April 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2027-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.