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 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, medical-devices.
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 ↗
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 (1,547 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 23, 2026.
Frequently Asked Questions
Common questions about this FDA recall.