BriteField illuminated Suction Device — Class II medical device recall Z-0007-2013
Terminated recall by Invuity, Inc., reported 2012-10-10, distributed nationwide. Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. I
| Recall number | Z-0007-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invuity, Inc., San Francisco, CA, United States |
| Recall initiated | 2012-05-12 |
| Classified | 2012-10-03 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2013-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 197 devices |
| Lot numbers | 09052901, 09061201, 09061801, 09061802, 09070201, 09070202, 09101602, 09101603, 09101604, 09120701, 09120702, 09120703, 10022602, 10022603, 10022604, 10030801, 10030802, 10030803, 10060102, 10060103, 10060104, 10060904, 10060905, 10FR, 12FR, 8FR |
| Model numbers | 10FR, 12FR, 1810000, 1810873, 18111073, 1811273, 1811873, 8FR |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0007-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.