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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

GE Medical Systems Information Technologies Inc: CRITIKON ONE-CUF Blood Pressure Cuffs Recalled for Inaccurate Measurements

Agency Publication Date: June 6, 2024
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Summary

GE Medical Systems is recalling approximately 23,180 GE HealthCare CRITIKON ONE-CUF blood pressure cuffs across 12 different models for infants, children, and adults. These cuffs may provide inaccurate non-invasive blood pressure readings, which could lead to improper medical treatment or a delay in care. Consumers should check their medical supplies for the specific model numbers and Global Trade Item Numbers (GTIN) listed in this recall. If you have these products, you should contact your healthcare provider or GE HealthCare for further instructions.

Risk

The blood pressure cuffs may fail to provide precise measurements, potentially leading to the misdiagnosis or incorrect treatment of patients. While no specific injuries have been detailed in this report, inaccurate readings in a clinical setting can hide dangerous health conditions or lead to unnecessary medical interventions.

What You Should Do

  1. Check your medical equipment for GE HealthCare CRITIKON ONE-CUF blood pressure cuffs with the following GTIN identifiers on the packaging: ONE-A1-1B (00195278573803), ONE-A1-2A (00195278576460), ONE-A2-1B (00195278573797), ONE-A1-1B-L (00195278573780), ONEA2-2A (00195278576477), ONE-A2-2A-L (00195278576484), ONE-A3-1B (00195278573810), ONE-A3-2A (00195278576491), ONE-P1-1B (00195278573834), ONE-P1-2A (00195278576507), ONE-P2-1B (00195278573827), or ONE-P2-2A (00195278576514).
  2. Verify the model numbers on your device: ONE-A1-1B, ONE-A1-2A, ONE-A2-1B, ONE-A1-1B-L, ONEA2-2A, ONE-A2-2A-L, ONE-A3-1B, ONE-A3-2A, ONE-P1-1B, ONE-P1-2A, ONE-P2-1B, or ONE-P2-2A.
  3. If you identify an affected blood pressure cuff, contact your healthcare provider or GE Medical Systems Information Technologies Inc. at their Milwaukee headquarters (9900 W Innovation Dr, Milwaukee, WI 53226) for further instructions and potential product resolution.
  4. Healthcare facilities should follow the instructions provided in the firm's notification letter sent on April 09, 2024.
  5. For additional information or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/instruction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: GE HealthCare CRITIKON ONE-CUF (Small Adult, 1 TB Bayonet, 17-25 CM)
Model / REF:
ONE-A1-1B
UPC Codes:
00195278573803
Product: GE HealthCare CRITIKON ONE-CUF (Small Adult, DINACLICK 80369-5, 17-25 CM)
Model / REF:
ONE-A1-2A
UPC Codes:
00195278576460
Product: GE HealthCare CRITIKON ONE-CUF (Adult, 1 TB Bayonet, 23-33 CM)
Model / REF:
ONE-A2-1B
UPC Codes:
00195278573797
Product: GE HealthCare CRITIKON ONE-CUF (Adult Long, 1 TB Bayonet, 23-33 CM)
Model / REF:
ONE-A1-1B-L
UPC Codes:
00195278573780
Product: GE HealthCare CRITIKON ONE-CUF (Adult, DINACLICK 80369-5, 23-33 CM)
Model / REF:
ONEA2-2A
UPC Codes:
00195278576477
Product: GE HealthCare CRITIKON ONE-CUF (Adult Long, DINACLICK 80369-5, 23-33 CM)
Model / REF:
ONE-A2-2A-L
UPC Codes:
00195278576484
Product: GE HealthCare CRITIKON ONE-CUF (Large Adult, 1 TB Bayonet, 31-40 CM)
Model / REF:
ONE-A3-1B
UPC Codes:
00195278573810
Product: GE HealthCare CRITIKON ONE-CUF (Large Adult, DINACLICK 80369-5, 31-40 CM)
Model / REF:
ONE-A3-2A
UPC Codes:
00195278576491
Product: GE HealthCare CRITIKON ONE-CUF (Infant, 1 TB Bayonet, 08-13 CM)
Model / REF:
ONE-P1-1B
UPC Codes:
00195278573834
Product: GE HealthCare CRITIKON ONE-CUF (Infant, DINACLICK 80369-5, 08-13 CM)
Model / REF:
ONE-P1-2A
UPC Codes:
00195278576507
Product: GE HealthCare CRITIKON ONE-CUF (Child, 1 TB Bayonet, 12-19 CM)
Model / REF:
ONE-P2-1B
UPC Codes:
00195278573827
Product: GE HealthCare CRITIKON ONE-CUF (Child, DINACLICK 80369-5, 12-19 CM)
Model / REF:
ONE-P2-2A
UPC Codes:
00195278576514

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94597
Status: Active
Manufacturer: GE Medical Systems Information Technologies Inc
Sold By: GE Medical Systems; Medical Distributors
Manufactured In: United States
Units Affected: 23,180/20-cuff boxes
Distributed To: Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Ohio, Pennsylvania, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.