RegWardenFDA facility compliance records
Recall

Class II — Terumo BCT, Inc.

Recalling firmTerumo BCT, INC.
Registered facilityView this company's 7 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonTerumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.
ProductAdiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Quantity660
DistributionNationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
Initiated2016-11-03
Classified2016-11-30
Terminated2017-03-02
Recall numberZ-0674-2017
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 — Terumo BCT, Inc. (Z-0674-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75589/

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