Invuity, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0007-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Product Classification:

Class II

Date Initiated: May 12, 2012

Date Posted: October 10, 2012

Recall Number: Z-0007-2013

Event ID: 62966

Reason for Recall:

Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time.

Status: Terminated

Product Quantity: 197 devices

Code Information:

Catalog numbers: 1810000, 1811273, 1811873, 1810873, 18111073 All possible lot numbers: 8Fr: 09061802, 09070201, 09070201, 09101602, 09120701, 10022602, 10030801, 10060102; 10Fr: 09061801, 09070202, 09120702, 09101603, 10022603, 10030802, 10060905, 10060904, 10060103; 12Fr: 09052901, 09061201, 09120703, 09101604, 10022604, 10030803, 10060104.

Distribution Pattern:

Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated