Data Foundry

Medical device recalls 2016

SEAL — Class II medical device recall Z-1837-2016

Terminated recall by Intuitive Surgical, Inc., reported 2016-06-08, distributed in PR. Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The par

Recall numberZ-1837-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntuitive Surgical, Inc., Sunnyvale, CA, United States
Recall initiated2016-05-09
Classified2016-05-27
Reported by FDA2016-06-08
Terminated2016-11-01
DistributedPR
Countries outside the USAT, AU, BE, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, KR, NL, NO, PT, QA, RO, SA, SE, SG, TR, TW
Quantity46,191 boxes
Reason classesspecification failure
Model numbers470380, 470380-04, 470380-05, 470380-06

Product

SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted during a surgical procedure.

Reason for recall

Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.

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-1837-2016. 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.