Data Foundry

Medical device recalls 2026

TS-10/TS-10H Tube Sorter — Class II medical device recall Z-1136-2026

Ongoing recall by Sysmex America, Inc., reported 2026-01-28, distributed nationwide. Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unint

Recall numberZ-1136-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSysmex America, Inc., Lincolnshire, IL, United States
Recall initiated2025-12-15
Classified2026-01-21
Reported by FDA2026-01-28
DistributedNationwide (US)
Quantity44 units
Serial numbers11246, 11250, 11281, 11303, 11336, 11405, 11420, 11453, 11524, 11533, 11539, 11541, 11610, 11611, 11635, 11711, 11753, 11774, 11788, 11790, 11795, 11834, 11907, 11918, 11950 and 19 more
Model numbersBN168792

Product

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17

Reason for recall

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

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-1136-2026. 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.