Z-2203-2019Class II

Endoscopic Cleaning Brushes sold in various Endoscopy Kits -

Name: Z-2203-2019 Endoscopic Cleaning Brushes sold in various Endoscopy Kits -
Creator: Medline Industries Inc
Published: 2019-04-25
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2019-04-25 / Terminated

FDA source

Medline Industries Inc began a recall of Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures on 2019-04-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2203-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-25
Posted: 2019-08-06
Terminated: 2020-12-16
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall: 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.
FDA root cause: Other
Action: On April 25, 2019, the firm sent Additional Items - Lots Affected URGENT RECALL MEDLINE INDUSTRIES IMMEDIATE ACTION REQUIRED letters to 61 consignees advising them of the problem, requesting that they apply stickers to any subject item/lot, and return the Verification Form. On May 15, 2019, the firm sent out a second recall letter to 36 consignees.
Quantity in commerce: 22204
Distribution: US Nationwide distribution in the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KY, LA, MO, NC, NH, NJ, NM, NY, NV, OH, OK, PA, RI, TN, TX, UT, WV, and WY
Product codes and lots: KIT NUMBERS: DYK1002DBDE, DYK1002DBSE, DYK1002DCB, and DYK1002SBC. LOT NUMBERS: GM10, GJ25, HA05, and HA20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2203-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2203-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06

Product code MNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)