FDA Device Intelligence
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STERILMED, INC. · Model AUT179096PF · UDI-DI 10888551013192

NLM Prescription
1
510(k) clearances
474
Adverse events (1 deaths)
18
Recalls
17
Facilities

Description

TROCAR VERSAPORT PLUS V2 W/ FIXATION CANNULA

Recalls

DateFirmReason
2026-08-19Stryker Sustainability SolutionsReusable access port system may crack or seperate during use.
2026-08-19Stryker Sustainability SolutionsReusable access port system may crack or seperate during use.
2026-08-19Stryker Sustainability SolutionsReusable access port system may crack or seperate during use.
2026-08-19Stryker Sustainability SolutionsReusable access port system may crack or seperate during use.
2026-08-19Stryker Sustainability SolutionsReusable access port system may crack or seperate during use.
2026-08-19Stryker Sustainability SolutionsReusable access port system may crack or seperate during use.
2018-06-19Stryker Sustainability SolutionsThrough investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall ex
2016-11-11Stryker Sustainability SolutionsAn increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
2015-07-10Stryker Sustainability SolutionsStryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packa
2015-06-01Stryker Sustainability SolutionsStryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.