MICROTEK 1 (UDI 00748426053957)Recalls & reported problems
Microtek Medical LLC · ROLLED PROBE COVER, 1-EACH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00748426053957), received between Oct 13, 2021 and Oct 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K961029); 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
Device problems
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 13, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE TIP OF THE PROBE COVER SHREDDED WHEN IT WAS REMOVED FROM THE PACKAGE AND A HOLE WAS OBSERVED WHEN ATTEMPTING TO APPLY IT ON THE PROBE. NO INFECTION OR PATIENT INJURY OR INFECTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12623961 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K961029. One submission often covers many models, so check the product and lot details in each record.
- Z-2332-2018 · Nov 22, 2017 · TerminatedECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used
- Z-2333-2018 · Nov 22, 2017 · TerminatedECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used a
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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