FDA Recall of Philips S4-1 Ultrasound Transducer
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA has announced a voluntary recall of 41 units of Philips S4-1 Ultrasound Transducer to clarify labeling on their useful life, affecting devices distributed nationwide in the United States.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "low" 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
Philips Ultrasound, Inc. is initiating a recall to provide clarification and labeling that defines the useful life of the Philips S4-1 Ultrasound Transducer devices.
Which Products Are Affected
The affected products are the Philips S4-1 Ultrasound Transducer with model numbers 989605458221, 989605458222, and 989605477101. The recall involves 41 units, identified by various UDIs such as (01)00884838085183(21)B25VV3 and serial numbers including B25VV3, B21XVK, and others listed in the recall details. Distribution occurred nationwide in the United States.
What You Should Do
Consumers who have the affected products should follow the initial firm notification, which was issued via letter, and contact the recalling firm for further instructions.
Why This Matters
This recall addresses potential issues with device labeling, ensuring accurate information for safe use, which is important for maintaining product reliability in medical settings.
Source
Attributed to the FDA; Recall Number Z-1625-2026.
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 (1,037 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.