Allergan Recalls Natrelle Tissue Expanders for Expired Shelf Life
Allergan is recalling Natrelle CUI Series Tissue Expanders because the shipped products were beyond their shelf life. The recall involves 23 units total, with 16 distributed in the US.
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. The hazard is the use of expired medical devices, which is a low-risk contamination or labeling/shelf-life issue without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Allergan Inc is recalling the Natrelle 133 and CUI Series Tissue Expanders. The recall is being conducted because the products that were shipped were found to be beyond their shelf life. These devices are designed for temporary implantation to develop a skin flap for reconstructive correction of a defect or to provide cover for a prosthetic implant.
The recall involves a total of 23 units, of which 16 were distributed in the United States. The source text notes a distribution pattern listed as "US in the state of Canada," which appears to be a data entry error in the original record, but the specific unit counts for the US are clearly stated. Specific serial and lot numbers for the affected units are listed in the agency's official records.
Healthcare providers and patients who have received these specific tissue expanders should contact their healthcare provider or Allergan for instructions on how to proceed. Consumers should not use the recalled devices if they are still in their possession.
The recalled product
- Product
- Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI…
- Manufacturer
- Allergan Inc
- Category
- Medical Device — Tissue Expander
- Hazard
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 (16)
- Serial No. (Lot No.) VE7507 (5F075-OEM)
- VE9273 (6H009-OEM)
- VF4561 (09H024-OEM)
- VF5340 (10A115-OEM)
- VE9272 (6H009-OEM)
- VF3627 (09E231-OEM)
- VE9117 (6F158-OEM)
- VF1201 (7K195-OEM)
- VF5396 (10A182-OEM)
- VF5341 (10A115-OEM)
- VF4923 (09J052-OEM)
- VF1420 (7L085-OEM)
- VF1327(7L043-OEM)
- VE7508 (5F075-OEM)
- VF1427 (7L085-OEM)
- VE9274 (6H009-OEM).
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Allergan Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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