CLASS II Device recall · Reported 7 Dec 2016 · FDA Enforcement Report
Adiprep Adipose Transfer System recalled by Terumo BCT
Terumo BCT is recalling Adiprep Adipose Transfer System, distributed nationwide in the US. The recall was initiated on 3 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0674-2017
- FDA event ID
- 75589
- Recalling firm
- Terumo BCT, Lakewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2016
- FDA classified
- 30 Nov 2016
- Reported
- 7 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 3 Nov 2016 | Recall initiated by company | |
| 30 Nov 2016 | Classified by FDA | +27 days |
| 7 Dec 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Where it was distributed
Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
Questions about this recall
Is Adiprep Adipose Transfer System recalled?
Yes. Terumo BCT recalled Adiprep Adipose Transfer System on 3 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0674-2017.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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