CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

Boston Scientific recalled

Boston Scientific Neuromodulation is recalling Boston Scientific, distributed nationwide in the US. The recall was initiated on 29 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 08714729905318/Lot # 35107836

Quantity recalled43 units

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-2404-2026
FDA event ID: 98941
Recalling firm: Boston Scientific Neuromodulation, Valencia, CA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Apr 2026
FDA classified: 11 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Other Medical Devices

Timeline

29 Apr 2026	Recall initiated by company
11 Jun 2026	Classified by FDA	+43 days
17 Jun 2026	Published in enforcement report	+6 days

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

Reason for recall

Sterile anchors my lack sterility assurance.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Where it was distributed

US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.

Nationwide Florida Louisiana Maryland Oklahoma South Carolina Utah

Questions about this recall

Is Boston Scientific recalled?

Yes. Boston Scientific Neuromodulation recalled Boston Scientific on 29 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2404-2026.

Why was it recalled?

Sterile anchors my lack sterility assurance.

Which lots are affected?

GTIN: 08714729905318/Lot # 35107836

Where was it sold?

US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.

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 21 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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