Medtronic Pocket Adaptor Kit Recall
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Medtronic Neuromodulation is recalling 31 units of 2x4 Pocket Adaptor Kits for Deep Brain Stimulation due to incorrect Use-By-Dates on labels.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 23, 2026 and geographically references United States. 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 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 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 affects the Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002 (Stimulator, electrical, implanted, for parkinsonian tremor). A total of 31 units are involved. Affected products are identified by the following GTINs and lot numbers: GTIN 00643169090866 (Lots VA368G3, VA36V7T); GTIN 00643169936584 (Lots VA3347Y, VA33481, VA33M8V, VA33M92, VA33T31, VA33T33, VA35B5D, VA35B5E, VA35WSP, VA35WSU); GTIN 00763000963040 (Lots VA35TTU, VA35TTV, VA368FZ, VA368G3, VA36V7T, VA36V8Q); GTIN 00763000968427 (Lots 0231980220, 0231980221, 0231980222); GTIN 00763000968434 (Lots 0231493884, 0231493885, 0231494066, 0231928923, 0231929188, 0231929189, 0231929192); GTIN 00763000968441 (Lots 0231367316, 0231367317). Distribution was nationwide in the US and to Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, and the United Kingdom. Recall number Z-2241-2026. Classification: Class II.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the affected devices.
Why This Matters
This Class II recall involves a device labeled with incorrect Use-By-Dates, which may pose temporary or reversible adverse health consequences.
Source
FDA recall Z-2241-2026, Medtronic Neuromodulation, Minneapolis, MN.
Original source: FDA Official Notice ↗
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