CLASS II Device recall · Reported 15 Jul 2015 · FDA Enforcement Report
Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc recalled
Allergan is recalling Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410, distributed in California, Indiana, Missouri, New Jersey, Virginia. The recall was initiated on 8 Jun 2015 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-1988-2015
- FDA event ID
- 71428
- Recalling firm
- Allergan, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jun 2015
- FDA classified
- 7 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Breast Implants
Timeline
| 8 Jun 2015 | Recall initiated by company | |
| 7 Jul 2015 | Classified by FDA | +29 days |
| 15 Jul 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
CA, IN, MO, NJ, VA
Questions about this recall
Why was it recalled?
Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
Which lots are affected?
Lot # Serial # Style #: 1703043, 14124459, MSZFX410; 1708499, 14164655, MSZFX410; 1801072, 14768661, MSZFX410; 1819375, 14905528, MSZFX410; 1819377, 14911183, MSZFX410; 1819377, 14911197, MSZFX410; 1819377, 14911180, MSZFX410; 1819378, 14907262, MSZFX410; 1819378, 14907266, MSZFX410.
Where was it sold?
CA, IN, MO, NJ, VA
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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Other Breast Implants recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | BBraun Medical Winged INF recalled | B Braun Medical | Device Malfunction | Nationwide |
| Device | CLASS II | B. Braun Winged Infusion, Single PK recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |