NATRELLE INSPIRA Single Use SizersRecalls & reported problems across all models
Allergan, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 16 models of NATRELLE INSPIRA Single Use Sizers by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Nov 3, 2022 and Sep 10, 2026 — classified as 10 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NATRELLE INSPIRA Single Use Sizers problems
Device problems
- Device Handling Problem8
- Difficult to Open or Remove Packaging Material6
- Device Appears to Trigger Rejection3
- Unsealed Device Packaging3
- Break2
- Material Rupture2
- Contamination1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Failure of Implant7
- Capsular Contracture3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
NATRELLE INSPIRA Single Use Sizers models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NATRELLE INSPIRA Single Use Sizers SSZ-F560Sizer, Mammary, Breast Implant Volume3 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F295Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F485Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-X495Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-X560Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-X615Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-X750Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F415Sizer, Mammary, Breast Implant Volume1 report
- NATRELLE INSPIRA Single Use Sizers SSZ-F745Sizer, Mammary, Breast Implant Volume1 report
- NATRELLE INSPIRA Single Use Sizers SSZ-L200Sizer, Mammary, Breast Implant Volume1 report
- NATRELLE INSPIRA Single Use Sizers SSZ-M360Sizer, Mammary, Breast Implant Volume1 report
- NATRELLE INSPIRA Single Use Sizers SSZ-M405Sizer, Mammary, Breast Implant Volume1 report
- NATRELLE INSPIRA Single Use Sizers SSZ-M520Sizer, Mammary, Breast Implant Volume1 report
- NATRELLE INSPIRA Single Use Sizers SSZ-X445Sizer, Mammary, Breast Implant Volume1 report
- NATRELLE INSPIRA Single Use Sizers SSZ-X545Sizer, Mammary, Breast Implant Volume1 report
- NATRELLE INSPIRA Single Use Sizers SSZ-X800Sizer, Mammary, Breast Implant Volume1 report
Recent NATRELLE INSPIRA Single Use Sizers adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Unsealed Device Packaging
Healthcare professional reported "opening a sizer in the operating room" and that the "inner packaging wasn't sealed all the way". There was no patient contact. This record is for the unimplanted device. Surgery was completed using a backup device.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50714069 ↗MalfunctionAug 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221336 ↗InjuryApr 24, 2026Material Rupture
SALES REPRESENTATIVE REPORTED "GEL SIZER RUPTURING DURING SURGERY". DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987431 ↗InjuryApr 3, 2026Off-Label Use; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) CAPSULAR CONTRACTURE GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS REPLACED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 24777379 ↗MalfunctionFeb 11, 2026Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "WHEN OPENING A SIZER THE PAPER WAS STICKING TO THE SIDES OF THE PLASTIC CONTAINER. THE REMAINING PAPER CAUSES A STERILITY ISSUE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS NOT IMPLANTED AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313335 ↗InjuryJan 8, 2026Difficult to Open or Remove Packaging Material
REGULATORY AGENCY, ON BEHALF OF HEALTHCARE PROFESSIONAL, REPORTED AN UNKNOWN SIDE SIZER DEVICE "TOP COVER OF THE PACKING WAS NOT PEELING CLEANLY AND LEFT SOME LEFTOVER PAPER ATTACHED TO THE PLASTIC CONTAINER" AND "THERE WAS NO SERIOUS HARM REPORTED". THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24014895 ↗InjuryNov 20, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "RUPTURED SIZER DURING INSERTION". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23610621 ↗InjuryOct 15, 2025Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method; Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, AND SIZER IMPLANTED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23281705 ↗MalfunctionOct 15, 2025Unsealed Device Packaging; Unsealed Device Packaging
HEALTHCARE PROFESSIONAL REPORTED "BREAST SIZER WAS OPENED AND ST NOTICED THAT THE PACKAGE WAS NOT COMPLETELY SEALED AND THEREFORE NOT STERILE". THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279884 ↗MalfunctionOct 15, 2025Device Handling Problem; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED "THAT THE INNER THERMOFORM AND OUTER THERMOFORM TRAYS WERE STUCK TOGETHER ON ALL THE SIZERS THAT WERE USED FOR THE CASE. WE WERE STILL ABLE TO USE THE SIZERS BUT POSES A GREAT CONCERN TO STERILITY." DEVICE HAS NOT BEEN IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279605 ↗InjurySep 10, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "DID NOT PEEL SMOOTHLY, WERE HARD TO GET SIZERS OUT OF CONTAINERS, LEFT PART OF PAPER ON STERILE LIDS, AND LIDS OF OUTER CONTAINER SHREDDED AND LEFT PAPER FILM" DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23022472 ↗MalfunctionSep 4, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "DID NOT PEEL SMOOTHLY, WERE HARD TO GET SIZERS OUT OF CONTAINERS, LEFT PART OF PAPER ON STERILE LIDS, AND LIDS OF OUTER CONTAINER SHREDDED AND LEFT PAPER FILM" DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22967827 ↗MalfunctionSep 4, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "DID NOT PEEL SMOOTHLY, WERE HARD TO GET SIZERS OUT OF CONTAINERS, LEFT PART OF PAPER ON STERILE LIDS, AND LIDS OF OUTER CONTAINER SHREDDED AND LEFT PAPER FILM" DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965390 ↗InjuryOct 23, 2023Unsealed Device Packaging; Unsealed Device Packaging
HEALTHCARE PROFESSIONAL REPORTED "BREAST SIZER WAS OPENED AND ST NOTICED THAT THE PACKAGE WAS NOT COMPLETELY SEALED AND THEREFORE NOT STERILE." THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17989459 ↗InjuryMay 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16963299 ↗
Other Allergan, Inc. products
- Natrelle Breast Implants1,167 models · 38,972 reports · 7 recalls
- Natrelle INSPIRA Breast Implants197 models · 15,057 reports · 1 recall
- NATRELLE Saline-Filled Breast Implants103 models · 7,892 reports · 1 recall
- Natrelle Inspira SoftTouch Breast Implants195 models · 6,571 reports · 1 recall
- NATRELLE Silicone-Filled Breast Implants128 models · 4,507 reports · 1 recall
- Natrelle Inspira Cohesive Breast Implants192 models · 2,949 reports · 1 recall
- JUVEDERM ULTRA XC3 models · 550 reports
- JUVEDERM ULTRA PLUS XC2 models · 324 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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