Natrelle INSPIRA Resterilizable Sizers MSZ-F365Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Rester Szr Sty MSZ-F365 Full · Class U
All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Resterilizable Sizers (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888628009318), received between Apr 11, 2025 and Apr 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K831566); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Remove Packaging Material1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
COMPANY REPRESENTATIVE REPORTED "BREAST SIZER WOULD NOT OPEN STERILELY. UNABLE TO USE PRODUCT". DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21826301 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K831566. One submission often covers many models, so check the product and lot details in each record.
- Z-0702-2020 · Nov 6, 2019 · TerminatedNATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (respons
- Z-1988-2015 · Jun 8, 2015 · TerminatedNatrelle 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
Other Mammary Sizer devices
- Natrelle INSPIRA Resterilizable Sizers MSZ-F450Allergan, Inc. · Mammary Sizer6 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F385Allergan, Inc. · Mammary Sizer4 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F560Allergan, Inc. · Sizer, Mammary, Breast Implant Volume3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F560Allergan, Inc. · Mammary Sizer3 reports
- MENTOR MemoryGel BOOST Resterilizable Gel Sizer RSZHPB480SMentor Texas L.P. · SIZER, MAMMARY, BREAST IMPLANT VOLUME3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F335Allergan, Inc. · Mammary Sizer3 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F295Allergan, Inc. · Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-X560Allergan, Inc. · Sizer, Mammary, Breast Implant Volume2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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