MICROTEK 1 (UDI 00748426107407)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00748426107407), received between Feb 18, 2022 and Aug 20, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Material Puncture/Hole; Material Puncture/Hole

  ADHESIVE ISSUES WERE REPORTED IN THE PROBE COVERS. THEY ARE PARTIALLY STICKY AND CAUSE A TEAR IN THE PROBE COVER. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856716 ↗
• MalfunctionMay 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT CUSTOMERS HAVE REPORTED A PROBLEM WITH THE PROBE COVER. WHEN INSTALLING THE PROTECTION ON THE PROBE, THE PART OF THE END OF THE COVER THAT IS SUPPOSED TO STICK TO THE PROBE DOES NOT. THE ADHESIVE REMAINS ON THE WHITE PART OF THE LABEL AND NOT ON THE COVER. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235389 ↗
• MalfunctionMar 15, 2024Loss of or Failure to Bond; Material Puncture/Hole; Loss of or Failure to Bond; Material Puncture/Hole

  IT WAS REPORTED THAT THE COVERS WERE STUCK TOGETHER AND BROKE WHEN USED. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18916385 ↗
• MalfunctionFeb 18, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PROBE COVER BROKE WHEN IT WAS PUT ON THE PROBE. NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560367 ↗

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-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-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-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
• 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-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-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.