Terumo BCT, Inc.
Terumo BCT, Inc. has 3 FDA enforcement events on this register (4 product records) between 2016 and 2017: 3 device; the busiest year was 2017 with 2.
0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in CO.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 20 Oct 2017 | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO | Device | Class II | 2 | Terminated |
| 20 Oct 2017 | 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 | Device | Class II | 1 | Terminated |
| 3 Nov 2016 | Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347. | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Terumo BCT, Inc. had?
3 enforcement events (4 product records) on this register, 2016–2017: 3 device.
Are any Terumo BCT, Inc. recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Terumo BCT, Inc. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.