Megadyne 0014ARecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10614559100158), received between Jul 25, 2022 and Apr 18, 2024 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K081791, K862221); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP FALLING OUT OF BOVIE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19138146 ↗
• MalfunctionFeb 20, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED PRODUCT CODE 0014 LABELED WITH LOT NUMBER RBMDUQ BUT ORDERED 0014A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738810 ↗
• MalfunctionJun 15, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133695 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125702 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125698 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125694 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125587 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125550 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125543 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125516 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125501 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125483 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125469 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125449 ↗
• MalfunctionJun 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NOT DURING A PROCEDURE THAT ALL THE PACKING AND LABELING WAS CORRECT BUT THE INCORRECT DEVICE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125421 ↗
• MalfunctionMar 30, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE CUSTOMER RECEIVED THE DEVICE AND THE OUTSIDE OF THE BOX SAYS 0014 BUT THE ITEM INSIDE IS A 0014A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645862 ↗
• MalfunctionMar 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OR SET UP CUSTOMER NOTICED THAT THE PRODUCT CODE ON THE PACKAGING WAS NOT THE PRODUCT INSIDE THE PACKAGE. PACKAGE WAS LABELED FOR A FOUR-INCH EXTENDED BLADE ELECTRODE BUT INSIDE THE PACKAGE IS A SIX- OR SIX-AND-A-HALF-INCH EXTENDED BLADE ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537632 ↗
• MalfunctionMar 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OR SET UP CUSTOMER NOTICED THAT THE PRODUCT CODE ON THE PACKAGING WAS NOT THE PRODUCT INSIDE THE PACKAGE. PACKAGE WAS LABELED FOR A FOUR-INCH EXTENDED BLADE ELECTRODE BUT INSIDE THE PACKAGE IS A SIX- OR SIX-AND-A-HALF-INCH EXTENDED BLADE ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537567 ↗
• MalfunctionMar 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OR SET UP CUSTOMER NOTICED THAT THE PRODUCT CODE ON THE PACKAGING WAS NOT THE PRODUCT INSIDE THE PACKAGE. PACKAGE WAS LABELED FOR A FOUR-INCH EXTENDED BLADE ELECTRODE BUT INSIDE THE PACKAGE IS A SIX- OR SIX-AND-A-HALF-INCH EXTENDED BLADE ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537560 ↗
• MalfunctionMar 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OR SET UP CUSTOMER NOTICED THAT THE PRODUCT CODE ON THE PACKAGING WAS NOT THE PRODUCT INSIDE THE PACKAGE. PACKAGE WAS LABELED FOR A FOUR-INCH EXTENDED BLADE ELECTRODE BUT INSIDE THE PACKAGE IS A SIX- OR SIX-AND-A-HALF-INCH EXTENDED BLADE ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537536 ↗
• MalfunctionMar 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OR SET UP CUSTOMER NOTICED THAT THE PRODUCT CODE ON THE PACKAGING WAS NOT THE PRODUCT INSIDE THE PACKAGE. PACKAGE WAS LABELED FOR A FOUR-INCH EXTENDED BLADE ELECTRODE BUT INSIDE THE PACKAGE IS A SIX- OR SIX-AND-A-HALF-INCH EXTENDED BLADE ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537498 ↗
• MalfunctionMar 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OR SET UP CUSTOMER NOTICED THAT THE PRODUCT CODE ON THE PACKAGING WAS NOT THE PRODUCT INSIDE THE PACKAGE. PACKAGE WAS LABELED FOR A FOUR-INCH EXTENDED BLADE ELECTRODE BUT INSIDE THE PACKAGE IS A SIX- OR SIX-AND-A-HALF-INCH EXTENDED BLADE ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537487 ↗
• MalfunctionMar 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OR SET UP CUSTOMER NOTICED THAT THE PRODUCT CODE ON THE PACKAGING WAS NOT THE PRODUCT INSIDE THE PACKAGE. PACKAGE WAS LABELED FOR A FOUR-INCH EXTENDED BLADE ELECTRODE BUT INSIDE THE PACKAGE IS A SIX- OR SIX-AND-A-HALF-INCH EXTENDED BLADE ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537470 ↗
• MalfunctionMar 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OR SET UP CUSTOMER NOTICED THAT THE PRODUCT CODE ON THE PACKAGING WAS NOT THE PRODUCT INSIDE THE PACKAGE. PACKAGE WAS LABELED FOR A FOUR-INCH EXTENDED BLADE ELECTRODE BUT INSIDE THE PACKAGE IS A SIX- OR SIX-AND-A-HALF-INCH EXTENDED BLADE ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537462 ↗
• MalfunctionMar 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OR SET UP CUSTOMER NOTICED THAT THE PRODUCT CODE ON THE PACKAGING WAS NOT THE PRODUCT INSIDE THE PACKAGE. PACKAGE WAS LABELED FOR A FOUR-INCH EXTENDED BLADE ELECTRODE BUT INSIDE THE PACKAGE IS A SIX- OR SIX-AND-A-HALF-INCH EXTENDED BLADE ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537449 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081791, K862221. One submission often covers many models, so check the product and lot details in each record.

• Z-0486-2010 · Oct 13, 2009 · Terminated
  E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expir