CRITIKON ONE-CUF Blood Pressure Cuffs (GE Healthcare) – Inaccurate Measurements (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L, ONE-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 5. ONEA2-2A, ONE-CUF, ADULT, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 6. ONE-A2-2A-L, ONE-CUF, ADULT LONG, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 7
Brand
GE Medical Systems Information Technologies Inc
Lot Codes / Batch Numbers
No serial numbers are on the blood pressure cuffs. GTIN NUMBERS: ONE-A1-1B - GTIN 00195278573803, ONE-A1-2A - GTIN 00195278576460, ONE-A2-1B - GTIN 00195278573797, ONE-A1-1B-L - GTIN 00195278573780, ONEA2-2A - GTIN 00195278576477, ONE-A2-2A-L GTIN 00195278576484, ONE-A3-1B - GTIN 00195278573810, ONE-A3-2A - GTIN 00195278576491, ONE-P1-1B - GTIN 00195278573834, ONE-P1-2A - GTIN 00195278576507, ONE-P2-1B - GTIN 00195278573827, and ONE-P2-2A - GTIN 00195278576514.
Products Sold
No serial numbers are on the blood pressure cuffs. GTIN NUMBERS: ONE-A1-1B - GTIN 00195278573803; ONE-A1-2A - GTIN 00195278576460; ONE-A2-1B - GTIN 00195278573797; ONE-A1-1B-L - GTIN 00195278573780; ONEA2-2A - GTIN 00195278576477; ONE-A2-2A-L GTIN 00195278576484; ONE-A3-1B - GTIN 00195278573810; ONE-A3-2A - GTIN 00195278576491; ONE-P1-1B - GTIN 00195278573834; ONE-P1-2A - GTIN 00195278576507; ONE-P2-1B - GTIN 00195278573827; and ONE-P2-2A - GTIN 00195278576514.
GE Medical Systems Information Technologies Inc is recalling GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL A due to Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Recommended Action
Per FDA guidance
Recall letters dated and issued on 4/9/2024 by the recalling firm explained the safety issue and actions to be taken by the customer/user. Those actions were to not use the affected products listed in the Affected Product Details section of the letter, use an alternate cuff for NIBP monitoring, and destroy all affected product per the customer facility procedures. A photograph of the product was embedded in the letter to show where to find the product name, model number, and GTIN number. The letter informs the consignee that GE HealthCare will replace the affected products with CRITIKON SOFT-CUF Blood Pressure Cuffs and a GE HealthCare representative will contact the consignee to arrange for this correction. An Acknowledgement Form was enclosed for completion and return.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026