DISPOSABLE BIOPSY FORCEPS FB-240URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170354144), received between Nov 15, 2021 and Jul 10, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A COLD BIOPSY PROCEDURE, WHILE USING DISPOSABLE BIOPSY FORCEPS, THE DEVICE DID NOT CLOSE PROPERLY. ANOTHER SET OF DISPOSABLE BIOPSY FORCEPS WERE OBTAINED, AND AN ADEQUATE TISSUE SAMPLE WAS COLLECTED. THE FORCEPS TORE THE PATIENT'S MUCOSA, AND A CLIP WAS REQUIRED TO CLOSE THE TEAR AND STOP BLEEDING. THE PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT WAS DISCHARGED AND ADVISED OF THE CLIP WITH INSTRUCTIONS ON IDENTIFYING SIGNS OF BLEEDING.

  Patient problems: Gastrointestinal Hemorrhage; Laceration(s)

  MAUDE report 22475295 ↗
• MalfunctionNov 15, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

  AS REPORTED, HANDPIECES SMASHED DURING SHIPPING. OUTER BOX DAMAGED . SOMETHING FELL ON TOP OF THE BOX CONTAINING THE FB-240U UNITS AND DAMAGED THREE PIECES WHERE THEY WERE STICKING OUT OF THE STERILE PACKAGING. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. DEVICE RETURN EVALUATION FOUND 3 DEVICES HAD HOLES ON THE FRONT OF THE PACKAGING EXPOSING THE INSTRUMENT. THIS REPORT IS RELATED TO REPORTS WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817548 ↗
• MalfunctionNov 15, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

  AS REPORTED, HANDPIECES SMASHED DURING SHIPPING. OUTER BOX DAMAGED . SOMETHING FELL ON TOP OF THE BOX CONTAINING THE FB-240U UNITS AND DAMAGED THREE PIECES WHERE THEY WERE STICKING OUT OF THE STERILE PACKAGING. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. DEVICE RETURN EVALUATION FOUND 3 DEVICES HAD HOLES ON THE FRONT OF THE PACKAGING EXPOSING THE INSTRUMENT. THIS REPORT IS RELATED TO REPORTS WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817392 ↗
• MalfunctionNov 15, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

  AS REPORTED, HANDPIECES SMASHED DURING SHIPPING. OUTER BOX DAMAGED . SOMETHING FELL ON TOP OF THE BOX CONTAINING THE FB-240U UNITS AND DAMAGED THREE PIECES WHERE THEY WERE STICKING OUT OF THE STERILE PACKAGING. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. DEVICE RETURN EVALUATION FOUND 3 DEVICES HAD HOLES ON THE FRONT OF THE PACKAGING EXPOSING THE INSTRUMENT. THIS REPORT IS RELATED TO REPORTS WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817193 ↗