Terumo BCT
FDA adverse event reports naming Terumo BCT as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: TERUMO BCT.
- Total reports
- 6,981
- Deaths
- 136
- Injuries
- 1,010
- Malfunctions
- 5,451
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Separator, Automated, Blood Cell, DiagnosticGKT5,091
- Separator, Automated, Blood Cell And Plasma, TherapeuticLKN1,677
- Container, Empty, For Collection & Processing Of Blood & Blood ComponentsKSR69
- Set, Transfer (Blood/Plasma)KSB44
- Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC32
- Apparatus, AutotransfusionCAC18
- Platelet And Plasma Separator For Bone Graft HandlingORG15
- Syringe, PistonFMF8
- Microfilter, Blood TransfusionCAK7
- Blood Establishment Computer Software And AccessoriesMMH6
Recent recalls
- 2016-11-30TerminatedError in labeling
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Terumo 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.
- TerminatedPackaging
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
- TerminatedProcess control
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
The 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 date of the recall. Since the product is noted as sterile, the clearance for K103340, K052925 and K991430 raises question if product was cleared with a sterility claim. Further post-market follow-up will be required to assess the safety risk of the product.
- TerminatedProcess control
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
The 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 date of the recall. Since the product is noted as sterile, the clearance for K103340, K052925 and K991430 raises question if product was cleared with a sterility claim. Further post-market follow-up will be required to assess the safety risk of the product.
Monitor Terumo BCT automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.