FDA Medical Device Recalls (openFDA)
Terumo BCT, Inc.: Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
- Recall number
- Z-0674-2017
- Recalling firm
- Terumo BCT, Inc.
- Product
- Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
- Status
- Terminated
- Initiated
- 2016-11-03
- Posted
- 2016-11-30
- Terminated
- 2017-03-02
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- Consignees will be notified on 11/07/16 via letter to contact the North America Terumo BCT support center at +1.877.842.7837 or +1.303.542.5050 if they have any affected product to issue a Return Goods Authorization for product return.
- Quantity
- 660
- Distribution
- Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
- Lot, serial or model codes
- Product Code: 51431, Lot Codes: 07Z9913; 07Z9933; 08Z9932; 09Z9908; 10Z9908 Product Code: 51432, Lot Codes: 08Z9907; 09Z9931. Product Code: 51433, Lot Codes: 08Z9901; 08Z9933. Product Code: 514001-347, Lot Codes: 05Z9956; 05Z9956; 07Z9917; 07Z9917; 07Z9917; 07Z9917; 05Z9956; 05Z9956; 07Z9917
- 510(k) numbers
- ["K121005"]
- PMA numbers
- not on file
- Product code
- MUU
- Firm FEI
- 1000117351
- Firm city
- Lakewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28