MICROTEK 1 (UDI 00748426053384)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00748426053384), received between Mar 21, 2024 and Mar 21, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER A BREAST LUMPECTOMY WITH SENTINEL NODE INJECTION IT WAS NOTED THAT THE NEO PROBE STERILE DRAPE HAD 2 SMALL HOLES WHICH CAUSED THE WOUND TO BE CONTAMINATED AND POTENTIALLY EXPOSED THE PATIENT TO PATHOGENS. THE HOLES WERE NOTED ON MICROTEK INTRAOPERATIVE PROBE REF NUMBER PC1308. THE HOLES WERE NOTED ON THE SEAMS OF THE DISTAL END OF THE COVER. THE PRODUCT INVOLVED WAS PC1308, 1 UNIT WERE REPORTED AS AFFECTED. NO PATIENT INJURIES, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18955905 ↗

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-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.
• 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