Allergan Recalls Natrelle Tissue Expanders Due to Expired Shelf Life
Allergan is recalling Natrelle 133 and CUI Series Tissue Expanders because the shipped products were beyond their 47-month shelf life.
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, but the source text explicitly states no illnesses or injuries were reported, and the hazard is limited to shelf-life expiration without confirmed harm, 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 was initiated because the products shipped were beyond their 47-month shelf life.
The affected products are intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed. A total of 167 units are involved in the recall, with 114 units distributed in the US.
Consumers and healthcare providers should stop using the affected tissue expanders and contact Allergan for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
- 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 (20)
- Serial No. (Lot No.) 11250691 (1030868)
- 11514564 (1107468)
- 11560447 (1120606)
- 14410441 (1745182)
- 14460177 (1752996)
- 14651643 (1782042)
- 14645258 (1781272)
- 14418851 (1747035)
- 14663483 (1784601)
- 14768174 (1800575)
- 11650852 (1146235)
- 11759596 (1175538)
- 11783801 (1181003)
- PX1195 (583159)
- VB9805 (1-116051)
- PG1537 (567007)
- PH8804 (569489)
- PK3108 (570078)
- PK3369 (570134)
- PK3381 (570134)
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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