Accessories, Cleaning Brushes, For Endoscope

Reports per year

Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-06-05Open, ClassifiedUnder Investigation by firm

  Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

  During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.

• 2025-06-05Open, ClassifiedUnder Investigation by firm

  ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

  During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.

• 2024-03-19Open, ClassifiedStorage

  Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"

  Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

• 2022-08-26Open, ClassifiedEnvironmental control

  METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

• 2018-10-11TerminatedUnder Investigation by firm

  Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

  There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.

• TerminatedNonconforming Material/Component

  Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neutral pH. Safe to use on all surgical instruments, flexible endoscopes and probes.

  The product is contaminated with Pseudomonas.

• TerminatedProcess design

  First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

  Affected lots may have exceeded its microbial limits.

• Open, ClassifiedUnder Investigation by firm

  MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE

  Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

• Open, ClassifiedUnder Investigation by firm

  MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS

  Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

• Open, ClassifiedUnder Investigation by firm

  MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW

  Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.