Terumo BCT, INC.
3 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (3)
Registered facilities (7)
- Terumo BCT, Inc.. FEI 1000117351 · CO
- Terumo BCT STERILIZATION SERVICES, Inc. FEI 3003094851 · CO
- Terumo BCT Vietnam Co., Ltd. FEI 3011720361 · VN
- TFB MANUFACTURING SRL FEI 3020981987 · CR
- Terumo BCT Europe N.V. FEI 3010425916 · BE
- TERUMO BCT, INC.- Littleton FEI 3017581284 · CO
- TERUMO BCT, LTD FEI 3002545766 · GB
Recalls & enforcement
- Class IITerminated2017-10-20Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
- Class IITerminated2017-10-20The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The expiration noted was not beyond initiation d…
- Class IITerminated2016-11-03Terumo 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.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Terumo BCT, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9002708-terumo-bct-inc/
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