MICROTEK 1 (UDI 00748426107377)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00748426107377), received between Nov 12, 2021 and May 7, 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.

• MalfunctionMay 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CAP ON THE STICKY AREA WAS INCORRECTLY POSITIONED, CAUSING THE PROBE COVER TO TEAR DURING HANDLING, A RECURRING EVENT. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980600 ↗
• MalfunctionDec 13, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE COVER IS GLUED TO THE OUTER PACKAGING. IT IS IMPOSSIBLE TO REMOVE THE COVER FROM THE PACKAGING BECAUSE IT REMAINS STUCK AND TEARS OFF IF YOU PULL IT OFF. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925654 ↗
• MalfunctionOct 11, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE STICKY PART OF THE COVER WAS PARTLY FOLDED OVER THE SHEATH. DURING INSTALLATION, THIS LED TO ITS TEARING. SO, ANOTHER COVER WAS USED. NO CLINICAL CONSEQUENCES ON THE PATIENT. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428611 ↗
• MalfunctionNov 12, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THERE WAS A TEAR IN THE PROBE COVER, WHICH WAS SPOTTED AT THE OPENING OF THE COVER. NO PATIENT INFECTION OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12806722 ↗

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-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-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
• 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-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-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.