Natrelle INSPIRA Resterilizable Sizers MSZ-F485Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Rester Szr Sty MSZ-F485 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 10888628009356), received between Jun 20, 2025 and Jun 20, 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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
COMPANY REPRESENTATIVE ON BEHALF OF HEALTHCARE PROFESSIONAL REPORTED THE BOX OF THE SIZER WAS MALFUNCTIONING AND REALLY HARD TO OPEN. LATER, HEALTHCARE PROFESSIONAL REPORTED "DEVICE PACKAGING DIFFICULT TO REMOVE, COMPROMISING STERILITY OF IMPLANT", NO PATIENT CONTACT. DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296100 ↗
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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