Z-0674-2017Class II

Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347

Name: Z-0674-2017 Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347
Creator: Terumo BCT, Inc.
Published: 2016-11-03
License: https://open.fda.gov/license/

Terumo BCT, Ltd / initiated 2016-11-03 / Terminated / root cause: labeling and UDI

FDA source

Terumo BCT, Inc. began a recall of Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347 on 2016-11-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0674-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-03
Posted: 2016-11-30
Terminated: 2017-03-02
Recalling firm: Terumo BCT, Ltd
Product: Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Product code: MUU System, Suction, Lipoplasty
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 660
Distribution: Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0674-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0674-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30

Product code MUU

K121005Class IIAdiprep Adipose Transfer SystemHarvest Technologies, Corp. / cleared 2012-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)