FDA Device recall Z-2227-2018

Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian

FDA Device
Class II
terminated
Published 2018-06-20

On 2018-06-20 the FDA classified a Class II recall of Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian by The Seaberg, citing 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 pat….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2227-2018
Classification	Class II
Status	terminated
Initiated	2018-05-02
Published	2018-06-20
Last updated	2026-09-13 11:54 UTC
Company	The Seaberg
Distribution	AR, AZ, CA, CO, CT, FL, ID, IL, KY, MD, ME, MI, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, WA

Product

Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian

Reason

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.

Identifiers

code_info	Lot #: XT1711, XT1712, XT1715, XT1716, XT1717, XT1719, XT1722, XT1723, XT1724, XT1726, XT1730, XT1731, XT1732, XT173… Lot #: XT1711, XT1712, XT1715, XT1716, XT1717, XT1719, XT1722, XT1723, XT1724, XT1726, XT1730, XT1731, XT1732, XT1734, XT1735, XT1736, XT1737, XT1738, XT1741, XT1744, XT1745, XT1748, XT1750, XT1751, XT1803, XT1804, XT1806, XT1807, XT1808

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2227-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.