PENTAX Medical CS2022ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14961333221582), received between Oct 1, 2024 and Oct 1, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  PER THE INITIAL REPORT, PENTAX INCORRECTLY PROCESSED AN ORDER (06-AUG-2024) FOR BRUSHES BY TRANSACTING BRUSH CS2022A LOT #0022404 INSTEAD OF CS5522A TWO BOXES. CUSTOMER RECEIVED AND USED 5 BRUSHES OUT OF 1 BOX OF 50 (RECEIVED 07-AUG-2024). CUSTOMER MENTIONED THEY DID NOT NOTICE RIGHT AWAY THAT IT WAS AN INCORRECT BRUSH. THE TWO BOXES WERE RETURNED INSIDE THE BOX FOR CS5522A, CONFIRMED BY CUSTOMER 16-SEP-2024. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342304 ↗
• MalfunctionOct 1, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  PER THE INITIAL REPORT, PENTAX INCORRECTLY PROCESSED AN ORDER (06-AUG-2024) FOR BRUSHES BY TRANSACTING BRUSH CS2022A LOT #0022404 INSTEAD OF CS5522A TWO BOXES. CUSTOMER RECEIVED AND USED 5 BRUSHES OUT OF 1 BOX OF 50 (RECEIVED 07-AUG-2024). CUSTOMER MENTIONED THEY DID NOT NOTICE RIGHT AWAY THAT IT WAS AN INCORRECT BRUSH. THE TWO BOXES WERE RETURNED INSIDE THE BOX FOR CS5522A, CONFIRMED BY CUSTOMER (B)(6) 2024. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342303 ↗
• MalfunctionOct 1, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  PER THE INITIAL REPORT, PENTAX INCORRECTLY PROCESSED AN ORDER (06-AUG-2024) FOR BRUSHES BY TRANSACTING BRUSH CS2022A LOT #0022404 INSTEAD OF CS5522A TWO BOXES. CUSTOMER RECEIVED AND USED 5 BRUSHES OUT OF 1 BOX OF 50 (RECEIVED 07-AUG-2024). CUSTOMER MENTIONED THEY DID NOT NOTICE RIGHT AWAY THAT IT WAS AN INCORRECT BRUSH. THE TWO BOXES WERE RETURNED INSIDE THE BOX FOR CS5522A, CONFIRMED BY CUSTOMER (B)(6) 2024. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342299 ↗
• MalfunctionOct 1, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  PER THE INITIAL REPORT, PENTAX INCORRECTLY PROCESSED AN ORDER ((B)(6) 2024) FOR BRUSHES BY TRANSACTING BRUSH CS2022A LOT #0022404 INSTEAD OF CS5522A TWO BOXES. CUSTOMER RECEIVED AND USED 5 BRUSHES OUT OF 1 BOX OF 50 (RECEIVED (B)(6) 2024). CUSTOMER MENTIONED THEY DID NOT NOTICE RIGHT AWAY THAT IT WAS AN INCORRECT BRUSH. THE TWO BOXES WERE RETURNED INSIDE THE BOX FOR CS5522A, CONFIRMED BY CUSTOMER (B)(6) 2024. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342291 ↗
• MalfunctionOct 1, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  PER THE INITIAL REPORT, PENTAX INCORRECTLY PROCESSED AN ORDER (06-AUG-2024) FOR BRUSHES BY TRANSACTING BRUSH CS2022A LOT#: 0022404 INSTEAD OF CS5522A TWO BOXES. CUSTOMER RECEIVED AND USED 5 BRUSHES OUT OF 1 BOX OF 50 (RECEIVED 07-AUG-2024). CUSTOMER MENTIONED THEY DID NOT NOTICE RIGHT AWAY THAT IT WAS AN INCORRECT BRUSH. THE TWO BOXES WERE RETURNED INSIDE THE BOX FOR CS5522A, CONFIRMED BY CUSTOMER 16-SEP-2024. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342278 ↗