RecallRadar

FDA Device recall Z-2226-2018

Part #: SAM XT-M, Model: Tactical Black or Military

On 2018-06-20 the FDA classified a Class II recall of Part #: SAM XT-M, Model: Tactical Black or Military 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

AgencyFDA Device
Recall numberZ-2226-2018
ClassificationClass II
Statusterminated
Initiated2018-05-02
Published2018-06-20
Last updated2026-09-13 11:54 UTC
CompanyThe Seaberg
DistributionAR, 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-M, Model: Tactical Black or Military

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, XT1713, XT1715, XT1719, XT1720, XT1721, XT1722, XT1723, XT1724, XT1725, XT1726, XT1727, XT172…Lot #: XT1711, XT1712, XT1713, XT1715, XT1719, XT1720, XT1721, XT1722, XT1723, XT1724, XT1725, XT1726, XT1727, XT1728, XT1729, XT1730, XT1731, XT1732, XT1734, XT1737, XT1738, XT1740, XT1742, XT1743, XT1744, XT1745, XT1746, XT1747, XT1748, XT1749, XT1750, XT1751, XT1752, XT1801, XT1803, XT1804, XT1805, XT1806, XT1807, XT1808, XT1809, XT1810, XT1811

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-2226-2018%22

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