RegWardenFDA facility compliance records
Recall

Class II — Sysmex America, Inc.

Recalling firmSYSMEX CORPORATION
Registered facilityView this company's 14 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonUnder specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
ProductTS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Quantity44 units
DistributionUS Nationwide.
Initiated2025-12-15
Classified2026-01-21
Recall numberZ-1136-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Sysmex America, Inc. (Z-1136-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98213/

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