CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report

Vapr¿ Tripolar 90" Degree Suction Electrodes recalled

DePuy Mitek, Inc., a Johnson & Johnson is recalling Vapr¿ Tripolar 90" Degree Suction Electrodes (, distributed in 11 states. The recall was initiated on 23 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesU1509202 and U1509162

Quantity recalled127

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-0479-2016
FDA event ID: 72703
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 23 Nov 2015
FDA classified: 23 Dec 2015
Reported: 30 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Nov 2015	Recall initiated by company
23 Dec 2015	Classified by FDA	+30 days
30 Dec 2015	Published in enforcement report	+7 days

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

Reason for recall

Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only

Product as listed by the FDA

VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)

Where it was distributed

Worldwide Distribution - US Distribution to the states of : AL, CA, CT, FL, KY, MN, MS, ND, NJ, NM and TX., and to the countries of: France, Netherlands and Norway.

Alabama California Connecticut Florida Kentucky Minnesota Mississippi North Dakota New Jersey New Mexico Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

U1509202 and U1509162

Where was it sold?

Worldwide Distribution - US Distribution to the states of : AL, CA, CT, FL, KY, MN, MS, ND, NJ, NM and TX., and to the countries of: France, Netherlands and Norway.

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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