ENCOR® SCCAN01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801741086691), received between Oct 17, 2019 and Sep 22, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23106569 ↗
• MalfunctionSep 22, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23106567 ↗
• MalfunctionSep 19, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093991 ↗
• MalfunctionSep 19, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093736 ↗
• MalfunctionJul 15, 2025Missing Information; Missing Information

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCOR VACUUM CANISTER. PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT BOTH THE EXTERNAL AND INTERNAL PACKAGES WERE MISSING THE MANUFACTURING DATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22504818 ↗
• MalfunctionDec 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A VACUUM ASSISTED BREAST BIOPSY PROCEDURE, THE LOT NUMBER AND EXPIRATION DATE ON THE BOX DIFFERS FROM THE LOT NUMBER AND EXPIRATION DATE ON THE PRODUCT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032772 ↗
• MalfunctionDec 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A VACUUM ASSISTED BREAST BIOPSY PROCEDURE, THE LOT NUMBER AND EXPIRATION DATE ON THE BOX DIFFERS FROM THE LOT NUMBER AND EXPIRATION DATE ON THE PRODUCT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032687 ↗
• MalfunctionMay 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A DIFFERENT PRODUCT CODE LABELED ON THE PRODUCT ITSELF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16938856 ↗
• MalfunctionOct 17, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL SCCAN01 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED A DEVICE MARKINGS ISSUE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE TWO MALFUNCTIONS, NO PATIENTS WERE INVOLVED AND AS SUCH THE AGE, WEIGHT, AND GENDER OF THE INTENDED PATIENT¿S WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9205692 ↗