The Recall Desk
SevereFDA (Devices)·Z-2226-2018·Announced 2018-06-20

Seaberg SAM XT-M Tourniquet Recalled for Potential Buckle Failure

The Seaberg Company is recalling SAM XT-M tourniquets because internal testing found stitches securing the buckle could fail, posing a risk of serious injury or death.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that a serious injury and/or death could occur as a result of the device failure, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk scenarios warranting a Severe rating.

Plain-English summary

The Seaberg Company Inc is recalling SAM XT-M tourniquets in Tactical Black or Military models. The recall covers specific lots distributed across the United States and multiple international markets, including Australia, Canada, China, and various European and Asian countries.

Internal testing indicated that the stitches securing the buckle to the nylon belt could fail. This defect poses a potential risk when the device is used on a human patient to stop arterial blood flow. The source text notes a remote chance that a serious injury and/or death could occur as a result of the device failure.

Consumers and healthcare providers should stop using the affected tourniquets immediately. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: XT1711
  • XT1712
  • XT1713
  • XT1715
  • XT1719
  • XT1720
  • XT1721
  • XT1722
  • XT1723
  • XT1724
  • XT1725
  • XT1726
  • XT1727
  • XT1728
  • XT1729
  • XT1730
  • XT1731
  • XT1732
  • XT1734
  • XT1737

Distribution

Part of a larger recall action

This product is one of 3 recalled by The Seaberg Company Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · The Seaberg Company Inc

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