Printer Paper Roll Maj-1497

• FDA 510(k) K103264 decided 23 Feb 2011 Active
• FDA GUDID UDI-DI 04953170234071 listed 21 Sep 2016 Listed

• • Ongoing Z-1613-2026 FDA Class II ·initiated 12 Feb 2026

  The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

• • Ongoing Z-0873-2026 FDA Class II ·initiated 31 Oct 2025

  Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

• • Ongoing Z-1009-2024 FDA Class II ·initiated 16 Jan 2024

  Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.

• • Ongoing Z-2447-2023 FDA Class II ·initiated 12 Jul 2023

  The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

• • Ongoing Z-2342-2023 FDA Class II ·initiated 26 May 2023

  Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

• • Terminated Z-0138-2017 FDA Class II ·initiated 23 Jun 2016

  New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.

1. 23 Feb 2011 Cleared FDA 510(k) K103264
2. 23 Jun 2016 Recall initiated FDA recalls Z-0138-2017
3. 21 Sep 2016 Listed FDA GUDID 04953170234071
4. 26 May 2023 Recall initiated FDA recalls Z-2342-2023
5. 12 Jul 2023 Recall initiated FDA recalls Z-2447-2023
6. 16 Jan 2024 Recall initiated FDA recalls Z-1009-2024
7. 31 Oct 2025 Recall initiated FDA recalls Z-0873-2026
8. 12 Feb 2026 Recall initiated FDA recalls Z-1613-2026

Trade name

Printer Paper Roll

Generic name

Medical printer paper

Model / Ref / Catalog

MAJ-1497, N2646200

Primary DI / UDI-DI

04953170234071

FDA product code

FEB

GMDN term

Medical printer paper

Device class

Class II

Regulation number

876.1500

GUDID distribution status

In Commercial Distribution

Category: Medical printer paper

Other devices filed under FDA product code FEB (ACCESSORIES, CLEANING, FOR ENDOSCOPE).

• MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor by STERIS CORPORATION
• BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS by BIOSEARCH MEDICAL PRODUCTS, INC.
• EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM by Advanced Sterilization Products, Inc.
• SCOPE BUDDY PLUS Endoscope Flushing Aid by MEDIVATORS INC.
• EVOTECH ECR by Advanced Sterilization Products, Inc.
• AUTO SUTURE* ANTI-FOG DEVICE** by United States Surgical, A Division of Tyco Healthc
• DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES by MEDIVATORS INC.
• ONE DIRECTIONAL CLEANING BRUSH by Endoscopy Support Services, Inc.
• RIWO SYSTEM TRAYS by RICHARD WOLF MEDICAL INSTRUMENTS CORP.
• OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 by Keymed, Inc.

• POWER CORD KR 4.5m MAJ-2398

  Class I

  CE/MDR

• Power Cord Dk Maj-2282

  Class I

  CE/MDR

• POWER CORD KR 4.5m MAJ-2396

  Class I

  CE/MDR

• Hdtv Monitor Remote / Communication Cable for Ucr 2.5M Maj-2047

  Class I

  CE/MDR

See all devices from Olympus Medical Systems Corporation →