Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2226-2018 — Part #: SAM XT-M, Model: Tactical Black or Military

U.S. FDA — Device Enforcement · United States · 2018-05-02 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2226-2018
Date of alert
2018-05-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
The Seaberg Company Inc
Product category
device
Product type
Devices
Reported risk: Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.