Allergan Recalls Expired Natrelle Breast Implant Sizers
Allergan is recalling 9 units of expired Natrelle 410cc Re-Sterilizable Breast Implant Sizers because they were shipped to the user level.
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 an expired medical device, which is a regulatory and quality control issue rather than a confirmed high-risk pathogen or structural defect causing immediate severe injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Allergan Inc is recalling the Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray with a double sterile barrier and enclosed in a labeled carton.
The recall is being conducted because the expired product was shipped to the user level. A total of 9 units are affected by this recall.
The affected units were distributed to California, Indiana, Missouri, New Jersey, and Virginia. Specific lot and serial numbers are listed in the agency's recall record. Consumers and healthcare providers should stop using these specific units and contact Allergan or their supplier for instructions on return or disposal.
The recalled product
- Product
- Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
- Manufacturer
- Allergan Inc
- Hazard
- Affected units
- 9
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 (17)
- Lot # Serial # Style #: 1703043
- 14124459
- MSZFX410
- 1708499
- 14164655
- 1801072
- 14768661
- 1819375
- 14905528
- 1819377
- 14911183
- 14911197
- 14911180
- 1819378
- 14907262
- 14907266
- MSZFX410.
Distribution
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