Site-Rite 9001C0212Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741037818), received between Apr 7, 2017 and Sep 10, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  "IT WAS REPORTED THAT A CONTAMINATION OF A WHITE FOREIGN MATERIAL WAS FOUND ON THE PROBE COVER. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12454096 ↗
• MalfunctionJan 28, 2021Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRESENCE OF A HAIR WAS OBSERVED DURING THE MATERIAL OPENING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11248324 ↗
• MalfunctionApr 13, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT "WE RECENTLY HAD A DEFECTIVE NEEDLE GUIDE KIT DURING A PROCEDURE." ON (B)(6) 2020: KIT WAS USED ON PATIENT, BUT NO HARM REPORTED. ON (B)(6) 2020 - A NEEDLE GUIDE KIT WAS RETURNED FOR EVALUATION. ALTHOUGH, THE NEEDLE GUIDES THEMSELVES WERE INTACT AND WITHOUT DAMAGE, A HAIR WAS FOUND ON THE CSR WRAP. THIS FILE WILL BE CONSERVATIVELY REPORTED FOR FOREIGN MATERIAL IN THE PACKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953766 ↗
• MalfunctionNov 20, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TRANSDUCER COVER HAS BEEN "DRILLED". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349477 ↗
• MalfunctionMay 9, 2018Hole In Material

  IT WAS REPORTED THAT THE DEVICE PRESENTED A HOLE. IT WAS FURTHER REPORTED THAT THE COVER PRESENTED A HOLE AS WELL. THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7498918 ↗
• MalfunctionApr 7, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A HAIR INSIDE THE STERILE PACKAGE. DEVICE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 6472689 ↗