MENTOR MemoryGel BOOST Resterilizable Gel Sizer RSZHPB325SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10081317030666), received between Oct 19, 2022 and Oct 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

1 other recall cover devices cleared under the same FDA submission (K062421); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A MENTOR MEMORYGEL BOOST RESTERILIZABLE GEL SIZER WAS IDENTIFIED TO HAVE BLACK DOTS PRIOR TO USE. NO ADVERSE EVENT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632762 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062421. One submission often covers many models, so check the product and lot details in each record.

• Z-0964-2015 · Dec 11, 2014 · Terminated
  MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.