CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report
Part #: SAM XT-M recalled by The Seaberg Company
The Seaberg Company is recalling Part #: SAM XT-M, distributed in 23 states. The recall was initiated on 2 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2226-2018
- FDA event ID
- 80140
- Recalling firm
- The Seaberg Company, Wilsonville, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2018
- FDA classified
- 14 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 May 2018 | Recall initiated by company | |
| 14 Jun 2018 | Classified by FDA | +43 days |
| 20 Jun 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Part #: SAM XT-M, Model: Tactical Black or Military
Where it was distributed
USA: CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, CT, WA, TX, KY, NC, NJ, PA OUS: Australia, Canada, China, Columbia, Costa Rica, Europe (EU), Hong Kong, Iceland, India, Iraq, Israel, Japan, Kenya, Korea, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, South Africa, Thailand, UAE
ArkansasArizonaCaliforniaColoradoConnecticutFloridaIdahoIllinoisKentuckyMarylandMaineMichiganMissouriMontanaNorth CarolinaNew JerseyNew YorkOhioOregonPennsylvania
Questions about this recall
Is Part #: SAM XT-M recalled?
Yes. The Seaberg Company recalled Part #: SAM XT-M on 2 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2226-2018.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
USA: CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, CT, WA, TX, KY, NC, NJ, PA OUS: Australia, Canada, China, Columbia, Costa Rica, Europe (EU), Hong Kong, Iceland, India, Iraq, Israel, Japan, Kenya, Korea, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, South Africa, Thailand, UAE
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Seaberg Company
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Part #: SAM XT-C recalled by The Seaberg Company | The Seaberg Company | Device Malfunction | 23 states |
| Device | CLASS II | Part #: SAM XT-C recalled by The Seaberg Company | The Seaberg Company | Device Malfunction | 23 states |
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