Z-2778-2017Class II

INVUITY(R) PhotonBlade(TM), REF PB1

Name: Z-2778-2017 INVUITY(R) PhotonBlade(TM), REF PB1
Creator: Invuity, Inc.
Published: 2017-06-12
License: https://open.fda.gov/license/

Invuity, Inc. / initiated 2017-06-12 / Terminated / root cause: design

FDA source

Invuity, Inc. began a recall of INVUITY(R) PhotonBlade(TM), REF PB1 on 2017-06-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2778-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Posted: 2017-07-28
Terminated: 2023-06-28
Recalling firm: Invuity, Inc.
Product: INVUITY(R) PhotonBlade(TM), REF PB1
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Official notices were sent to customers via FedEx overnight on 6/14/17. Email notices were sent to the sales personnel 06/12/2017 regarding the return of their trunk stock inventory and asking them to also contact customers who had been sent letters.
Quantity in commerce: 1328 units
Distribution: nationwide
Product codes and lots: All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2778-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2778-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27

Product code GEI

K162053Class IIPhotonBladeInvuity, Inc. / cleared 2016-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)