Accessories, Cleaning Brushes, For Endoscope
FDA product code MNL · Class I (low risk) · 21 CFR 876.1500 · Gastroenterology, Urology
4510(k) clearances
0PMA approvals
24recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950689 | UcbMNL · Traditional | Cox Medical Ent., Inc. | 03/06/1995SE |
| K946293 | Mill-Rose Scope Cleaning BrushMNL · Traditional | Mill-Rose Laboratory | 02/16/1995SE |
| K892218 | Endo-SpongeMNL · Traditional | Endovations | 05/31/1989SE |
| K874239 | Cleaning BrushMNL · Traditional | Endovations | 12/29/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1910-2025 Class II | ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples… | Healthmark Industries Co., Inc. | 05/02/2025Open, Classified |
| Z-1909-2025 Class II | Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples… | Healthmark Industries Co., Inc. | 05/02/2025Open, Classified |
| Z-1313-2024 Class II | Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures… | Mckesson Medical-Surgical Inc. Corporate… | 01/09/2024Open, Classified |
| Z-1621-2022 Class II | METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1221-2022 Class II | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FSSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has… | MEDLINE INDUSTRIES, LP - Northfield | 04/21/2022Open, Classified |
| Z-1220-2022 Class II | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FSSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has… | MEDLINE INDUSTRIES, LP - Northfield | 04/21/2022Open, Classified |
| Z-1219-2022 Class II | MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAWSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has… | MEDLINE INDUSTRIES, LP - Northfield | 04/21/2022Open, Classified |
| Z-1218-2022 Class II | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FSSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has… | MEDLINE INDUSTRIES, LP - Northfield | 04/21/2022Open, Classified |
| Z-1217-2022 Class II | MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSESporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has… | MEDLINE INDUSTRIES, LP - Northfield | 04/21/2022Open, Classified |
| Z-2766-2020 Class II | Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use…Potential risk of brush detachment during cleaning. | Medline Industries Inc | 07/09/2020Terminated |
| Z-1925-2019 Class II | First Step Draco Pad, Product Number EP-4DThis product has been contaminated with Stenotrophomonas lactiubi. | Madison Polymeric Engineering | 05/08/2019Terminated |
| Z-1924-2019 Class II | Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number…This product has been contaminated with Stenotrophomonas lactiubi. | Madison Polymeric Engineering | 05/08/2019Terminated |
| Z-2203-2019 Class II | Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes…Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the… | Medline Industries Inc | 04/25/2019Terminated |
| Z-0969-2019 Class II | Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered…The product is contaminated with Pseudomonas. | Madison Polymeric Engineering | 12/14/2018Terminated |
| Z-3210-2018 Class II | Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a.…There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is… | Medline Industries Inc | 06/15/2018Terminated |
| Z-1900-2018 Class II | Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Madison Polymeric Engineering | 03/21/2018Terminated |
| Z-1899-2018 Class II | Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Madison Polymeric Engineering | 03/21/2018Terminated |
| Z-1898-2018 Class II | First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Madison Polymeric Engineering | 03/21/2018Terminated |
| Z-1897-2018 Class II | First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Madison Polymeric Engineering | 03/21/2018Terminated |
| Z-1896-2018 Class II | First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Madison Polymeric Engineering | 03/21/2018Terminated |
| Z-1895-2018 Class II | First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Madison Polymeric Engineering | 03/21/2018Terminated |
| Z-1182-2018 Class II | First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of…Affected lots may have exceeded its microbial limits. | Madison Polymeric Engineering | 11/03/2017Terminated |
| Z-1389-2016 Class III | Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning…Foreign material in container | Cygnus Medical | 03/17/2016Terminated |
| Z-1333-2016 Class II | ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for…Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel… | Karl Storz Endovision, Inc. | 02/29/2016Terminated |