Data Foundry

Medical device recalls 2018

Part #: SAM XT-C — Class II medical device recall Z-2228-2018

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 numberZ-2228-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmThe Seaberg Company Inc, Wilsonville, OR, United States
Recall initiated2018-05-02
Classified2018-06-14
Reported by FDA2018-06-20
Terminated2020-07-01
DistributedAR, 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 USAE, AU, CA, CN, CR, HK, IL, IN, IQ, IS, JP, KE, KR, LB, MY, RU, SA, SG, TH, ZA
Lot numbersXT1808, XT1809, XT1810

Product

Part #: SAM XT-C, Model: Hi-Viz Blue

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-2228-2018. 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.