FDA Device Intelligence
HomeDevice types › MNL

Accessories, Cleaning Brushes, For Endoscope

FDA product code MNL · Class 1 · Gastroenterology, Urology

4,319
Registered devices
664
Adverse events
24
Recalls
4
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-05-02Healthmark Industries Co., Inc.During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes a
2025-05-02Healthmark Industries Co., Inc.During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes a
2024-01-09Mckesson Medical-Surgical Inc. Corporate OfficeFacility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated ran
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot
2022-04-21MEDLINE INDUSTRIES, LP - NorthfieldSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
2022-04-21MEDLINE INDUSTRIES, LP - NorthfieldSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
2022-04-21MEDLINE INDUSTRIES, LP - NorthfieldSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
2022-04-21MEDLINE INDUSTRIES, LP - NorthfieldSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
2022-04-21MEDLINE INDUSTRIES, LP - NorthfieldSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
2020-07-09Medline Industries IncPotential risk of brush detachment during cleaning.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.