Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2027-2024 — 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-

U.S. FDA — Device Enforcement · United States · 2024-04-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2027-2024
Date of alert
2024-04-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Medical Systems Information Technologies Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00195278573803
Reported risk: Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.