VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog… recallZ-0479-2016 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Nov 23, 2015
Class II Terminated All recalls posted in December 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process control
What the company is doing
DePuy sent an Urgent Field Safety Notice dated November 23, 2015, mailed FEDEx to all affected Customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were asked to take the following steps: 1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located in your facility. 2. Review, complete, sign and return the attached business reply form in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any potentially affected product has been forwarded to another facility, contact the firm. 5. Keep a copy of this notice. For further questions please call (508) 880-8100.
Recall details
- Recall number
- Z-0479-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 23, 2015
- Posted by the FDA
- Dec 23, 2015
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- 127
- Product code
- GEI
- FDA submissions
- K143475
- Distribution
- 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.
Product description
VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Code information (models, lots, serial numbers)
U1509202 and U1509162
Other devices under the same FDA submission
2 devices cleared under K143475 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VAPR COOLPULSE 225031Medos International Sàrl · Electrosurgical, cutting & coagulation & accessories27 reports
- VAPR COOLPULSE 225032Medos International Sàrl · Electrosurgical, cutting & coagulation & accessories14 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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