Part #: SAM XT-C — Class II medical device recall Z-2227-2018
Terminated recall by The Seaberg Company Inc, reported 2018-06-20, distributed in AR, AZ, CA, CO, CT, FL, ID, IL…. Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nyl
| Recall number | Z-2227-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Seaberg Company Inc, Wilsonville, OR, United States |
| Recall initiated | 2018-05-02 |
| Classified | 2018-06-14 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-07-01 |
| Distributed | AR, AZ, CA, CO, CT, FL, ID, IL, KY, MD, ME, MI, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, WA |
| Countries outside the US | AE, AU, CA, CN, CR, HK, IL, IN, IQ, IS, JP, KE, KR, LB, MY, RU, SA, SG, TH, ZA |
| Lot numbers | 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 |
Product
Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2227-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.