FDAClass IIAugust 2, 2017

INVUITY(R) PhotonBlade(TM) recall

INVUITY(R) PhotonBlade(TM), REF PB1

Why was INVUITY(R) PhotonBlade(TM) recalled?

A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lot Numbers

Product
INVUITY(R) PhotonBlade(TM), REF PB1
Recalling firm
Invuity, Inc.
Quantity
1328 units
Distribution
nationwide
Recall date
August 2, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls