MICROTEK 1 (UDI 00748426090204)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00748426090204), received between Nov 22, 2019 and Dec 4, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (5 reports).

8 other recalls cover devices cleared under the same FDA submission (K882724); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A LUMPECTOMY WITH SENTINEL LYMPH NODE BIOPSY, THE PROTECTIVE STERILE PROBE COVER WAS FOUND TO HAVE A BREACH AT THE TIP AFTER THE PROCEDURE. BLOOD WAS OBSERVED ON THE UNDERLYING PROBE, WHICH IS NOT STERILIZABLE AND IS INTENDED TO REMAIN ISOLATED FROM TISSUE CONTACT. THE BREACH COMPROMISED THE STERILE BARRIER AND POSED A POTENTIAL INFECTION RISK. THE AFFECTED COVER WAS DISCARDED, AND A REPLACEMENT STERILE COVER WAS APPLIED. NO PATIENT HARM OCCURRED, AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717237 ↗
• MalfunctionMar 19, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PROBE COVER WAS PIERCED. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935770 ↗
• MalfunctionNov 18, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THERE WAS A TEAR IN THE PROBE COVER. NO PATIENT INJURY OR INFECTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839844 ↗
• MalfunctionNov 22, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER A PROCEDURE, BLOOD WAS OBSERVED ON THE TIP OF THE PROBE AFTER REMOVING THE STERILE DISPOSABLE COVER. THE COVER WAS PROBABLY DAMAGED DURING THE PROCEDURE OR WAS DEFECTIVE. NO PATIENT COMPLICATIONS WERE HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365898 ↗
• MalfunctionNov 22, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER A PROCEDURE, A RUPTURE OF THE COVER INTRAOPERATIVELY DURING THE SEARCH FOR SENTINEL LYMPH NODE. TEAR OBSERVED AT THE END OF THE SURGERY AT THE TIME OF REMOVAL OF THE COVER OF THE PROBE. NO PATIENT COMPLICATIONS WERE HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365850 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K882724. One submission often covers many models, so check the product and lot details in each record.

• Z-0753-2017 · Nov 30, 2016 · Terminated
  Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
• Z-0974-2014 · Jul 12, 2013 · Terminated
  5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the orde
• Z-0947-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
• Z-0946-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
• Z-0943-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
• Z-0948-2014 · Jul 2, 2013 · Terminated
  Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
• Z-0945-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS
• Z-0944-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS