Recall of Philips OMNI III TEE Ultrasound Transducer Announced
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Philips Ultrasound, Inc. has initiated a voluntary recall of 75 units of the Philips OMNI III TEE Ultrasound Transducer to provide clarification on its useful life.
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 recalling the Philips OMNI III TEE Ultrasound Transducer to provide clarification and labeling to define the useful life of the ultrasound transducers in the field. This recall is classified as Class III and was initiated voluntarily by the firm.
Which Products Are Affected
The affected product is the Philips OMNI III TEE Ultrasound Transducer, with model numbers including 989605440701, 989605440702, 989605440772, and 989803001561. The recall involves 75 units distributed nationwide in the United States. Specific UDIs include (01)00884838067585(21)02ZTTT, (01)00884838067585(21)B0X7MD, and others as listed in the code info. Serial numbers affected include 02ZTTT, 02DFBP, B0X7MD, and many more. The recall number is Z-1624-2026.
What You Should Do
Consumers should follow the initial firm notification, which was sent via letter, for instructions on this voluntary recall. Contact Philips Ultrasound, Inc. at their address: 1 Echo Dr, Reedsville, PA 17084-8603, for information on returns or further actions related to the affected devices.
Why This Matters
This recall addresses potential issues with the useful life of medical devices, ensuring proper labeling to maintain safety standards in healthcare settings. It affects 75 units nationwide, emphasizing the importance of accurate product information for medical professionals.
Source
Attribution: FDA. For more information, visit the FDA website and search for recall number Z-1624-2026.
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 (1,507 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.