Recall of Philips Mini Multi TEE Ultrasound Transducer

FDA Recalls low FDA · · United States

Philips Ultrasound, Inc. is voluntarily recalling 11 units of the Philips Mini Multi TEE Ultrasound Transducer to provide clarification on the useful life of the devices, as distributed nationwide in the United States.

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 initiating a voluntary recall to provide clarification and labeling that defines the useful life of the Philips Mini Multi TEE Ultrasound Transducer. This action was taken to ensure proper information is available for the devices.

Which Products Are Affected

The affected products are the Philips Mini Multi TEE Ultrasound Transducer with Model No. 989605439241, 989605439242, and 21381A. The units include UDI codes such as (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, and (01)00884838067547(21)B01639, along with Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, and B01639. A total of 11 units are affected, distributed US nationwide.

What You Should Do

Consumers should follow the initial firm notification, which is a letter, for further instructions from Philips Ultrasound, Inc. Contact the recalling firm for details on returns or refunds.

Why This Matters

This recall involves medical devices and aims to clarify their useful life, potentially affecting safe usage in healthcare settings across the United States.

Source

Attribution: FDA. For more information, visit the FDA website and search for recall number Z-1622-2026.

Source: FDA Official Notice

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Frequently Asked Questions

What is this fda recalls alert about?
Philips Ultrasound, Inc. is voluntarily recalling 11 units of the Philips Mini Multi TEE Ultrasound Transducer to provide clarification on the useful life of the devices, as distributed nationwide in the United States.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.