Terumo BCT Recalls Adiprep Adipose Transfer System Due to Labeling Error
Terumo BCT is voluntarily recalling 660 units of the Adiprep Adipose Transfer System because incorrect labeling could cause operator confusion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that could lead to operator confusion, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Terumo BCT, Inc. is conducting a voluntary field action for the Harvest: Adiprep Adipose Transfer System. The recall involves 660 units of the device, which are identified by specific product and lot codes listed in the official notice.
The reason for the recall is that the affected products are incorrectly labeled, creating a potential for operator confusion. The devices were distributed nationwide, to Canadian consignees, and to other foreign consignees. The source text does not indicate any distribution to VA, government, or military consignees.
No specific instructions for consumers are provided in the source text, as the notice focuses on the voluntary field action and the labeling defect. Users of the device should refer to the official FDA recall notice for specific guidance on handling the affected units.
The recalled product
- Product
- Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
- Manufacturer
- Terumo BCT, Inc.
- Affected units
- 660
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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
Distribution
Distributed nationwide across the United States.
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