Masimo Radius VSM Disposable NIBP Cuff Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Masimo Corporation is recalling 1,028 Radius VSM Disposable NIBP Cuffs (REF 4825, 4826) due to potential ECG alarm errors and rough edges on cuffs that may cause skin irritation.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Masimo Corporation initiated a recall of Radius VSM Disposable NIBP Cuffs after identifying two issues: the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true alarms; and small and medium size blood pressure cuffs may contain rough edges that could result in skin irritation or redness.
Which Products Are Affected
The recall affects Radius VSM Disposable NIBP Cuff, REF: 4825, 4826. A total of 1,028 units are involved. Affected lot numbers include: 4825/00843997006989/21G6S, 22JHV, 23H03, 23J05, 24DBV, 24NGG, 25ADG, E21D31, E21JWM, E23FVD; and 4826/10843997006993/21HVX, 22ELB, 23G31, 23H04, 23HWL, 23J06, 24DBW, 24MNP, 24NGF, 25ADF, E21D32, E21F04, E21JFA, E21KHK. Distribution was worldwide, including the United States (states: OK, CA, MD, MA, NY, UT, NC, TN, MN, TX, OH, PA, VA) and countries including Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, and others. The recall number is Z-2671-2026. This is a Class II recall.
What You Should Do
Consumers and healthcare providers should follow guidance from the recalling firm, Masimo Corporation, located at 52 Discovery, Irvine, CA 92618-3105.
Why This Matters
The recall addresses potential device malfunctions that could lead to alarm fatigue or minor skin irritation in clinical settings.
Source
FDA recall Z-2671-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,500 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.