Masimo Radius VSM ECG Pre-Connected Set Recall
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Masimo Corporation is recalling 772 units of Radius VSM ECG pre-connected Set (REF 4842, 4695) due to ECG alarm errors and rough edges on blood pressure cuffs.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 6, 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, Devices.
What Happened
Masimo Corporation initiated a voluntary recall of the Radius VSM ECG pre-connected Set after identifying two issues: the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger alarms on patients with normal heart rates, potentially distracting clinicians from true alarms and delaying treatment; additionally, small and medium blood pressure cuffs may have rough edges that could cause skin irritation or redness.
Which Products Are Affected
The recall covers Radius VSM ECG pre-connected Set, REF: 4842, 4695. Affected lots include REF/UDI-DI/Lot: 4842/10843997011003/25AJH, 25KMA, 25MSC and 4695/10843997016015/24N17, 25BBJ, 25DMH, 25FBR, 24KLV, 24N17, 25AGZ, 25BBJ, 25D10, 25DMH, 25FBR, 25GJM, 25KBF. A total of 772 units are affected. Distribution includes US nationwide in the states of OK, CA, MD, MA, NY, UT, NC, TN, MN, TX, OH, PA, VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, Malta, Oman, United Arab Emirates, Martinique, Netherlands, Cyprus, Kuwait, Czech Republic, United Kingdom, Croatia, Switzerland, Belgium, Singapore, Romania, Colombia, Hong Kong, Israel, Finland, Poland, New Zealand, Tunisia, Chile, Algeria, Canada, Denmark, Palestinian Territory, Qatar, Greece, Paraguay. This is FDA recall number Z-2670-2026, Class II.
What You Should Do
The recalling firm, Masimo Corporation, initiated the recall via letter. Consumers and healthcare providers should follow instructions provided in the notification for the affected devices.
Why This Matters
The recall addresses potential device malfunctions that could lead to alarm fatigue or skin irritation in clinical settings.
Source
FDA Recall Z-2670-2026 - Masimo Corporation, Irvine, CA
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 (1,807 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.