Recall of Philips OMNI III TEE Ultrasound Transducer Announced
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 recalls alert 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar alerts have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized fda recalls advisory is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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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.
Source: FDA Official Notice