CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report

Ventriculostomy Kit recalled by Medtronic Neurosurgery

Medtronic Neurosurgery is recalling Ventriculostomy Kit, distributed nationwide in the US. The recall was initiated on 17 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00673978947396, Lot: 2025-08779

Quantity recalled167

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2768-2026
FDA event ID: 99342
Recalling firm: Medtronic Neurosurgery, Haltom City, TX
Classification: Class II
Status: Ongoing
Recall initiated: 17 Jun 2026
FDA classified: 21 Jul 2026
Reported: 29 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Jun 2026	Recall initiated by company
21 Jul 2026	Classified by FDA	+34 days
29 Jul 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.

Product as listed by the FDA

Ventriculostomy Kit, REF: 46154

Where it was distributed

Worldwide - US Nationwide distribution in the states of UT, AL, CA, NC, GA, AR, LA, KY, LA, KY, IL, OK and the country of Costa Rica.

Nationwide Alabama Arkansas California Georgia Illinois Kentucky Louisiana North Carolina Oklahoma Utah

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 00673978947396, Lot: 2025-08779

Where was it sold?

Worldwide - US Nationwide distribution in the states of UT, AL, CA, NC, GA, AR, LA, KY, LA, KY, IL, OK and the country of Costa Rica.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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