Keller Funnel 2Recalls & reported problems across all models

We found 2 models of Keller Funnel 2 by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2021 and Sep 14, 2026 — classified as 3 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Inadequate Lubrication” (41 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Keller Funnel 2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 14, 2024Open, Classified

   Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

   Z-1694-2024 · Root cause: Process design · Recall details · FDA record ↗

Most reported Keller Funnel 2 problems

Keller Funnel 2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Keller Funnel 2 HA-005

  Kit, Surgical Instrument, Disposable
  1 recall39 reports
• Keller Funnel 2 HA-001

  Kit, Surgical Instrument, Disposable
  9 reports

Recent Keller Funnel 2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break; Inadequate Lubrication

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764080 ↗
• MalfunctionAug 13, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243333 ↗
• MalfunctionMar 9, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545846 ↗
• MalfunctionMar 9, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545664 ↗
• MalfunctionMar 9, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545523 ↗
• MalfunctionMar 9, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545270 ↗
• MalfunctionMar 5, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS, WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515831 ↗
• MalfunctionMar 5, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515763 ↗
• MalfunctionMar 3, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " , WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS, WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492896 ↗
• MalfunctionMar 2, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS, WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491457 ↗
• MalfunctionFeb 25, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444294 ↗
• MalfunctionFeb 25, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444073 ↗
• MalfunctionFeb 24, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED ¿WHEN USING THE KELLER FUNNEL, IT DOES NOT SLIP DESPITE BEING WELL HYDRATED. THIS DEFORMED THE IMPLANT. THE SURGEON HAD TO TAKE ANOTHER IMPLANT AND A NEW KELLER FUNNEL." DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431550 ↗
• MalfunctionNov 21, 2025Microbial Contamination of Device; Microbial Contamination of Device

  HEALTHCARE PROFESSIONAL REPORTED ¿WHEN THEY OPENED THE PACKAGING, KELLER FUNNEL HAD HAIR ON IT. THE FUNNEL WAS NOT USED¿. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622579 ↗
• MalfunctionOct 29, 2025Improper or Incorrect Procedure or Method; Inadequate Lubrication; Improper or Incorrect Procedure or Method; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23419854 ↗

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