Medtronic Pocket Adaptor Kit Recall for Incorrect Use-By Dates

Source: FDA · Worldwide

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Medtronic Neuromodulation is recalling 275 units of 1x4 Pocket Adaptor Kits (Model 64001) labeled with incorrect use-by dates.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 23, 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 read it 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 notices 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 recall 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

Medtronic Neuromodulation initiated a voluntary recall because a limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

Which Products Are Affected

The recall covers Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor. A total of 275 units are affected. Specific GTINs and lot numbers include GTIN 00643169090866 (Lots VA368G3, VA36V7T), GTIN 00643169936584 (multiple lots including VA3347Y, VA33481), and numerous additional GTINs and lots listed in recall Z-2240-2026. Distribution was worldwide, including US Nationwide and the countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom.

What You Should Do

No specific consumer action steps are provided in the recall notice.

Why This Matters

This Class II recall involves labeling errors on devices used for deep brain stimulation that could affect proper identification of expiration dates.

Source

FDA recall Z-2240-2026, Medtronic Neuromodulation, Minneapolis, MN. Report date 20260603.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medtronic Neuromodulation is recalling 275 units of 1x4 Pocket Adaptor Kits (Model 64001) labeled with incorrect use-by dates.
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 "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.