The Recall Desk
HighFDA (Devices)·Z-3210-2018·Announced 2018-09-26

Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk

Medline Industries is recalling single-use endoscopic cleaning brushes because they may detach during cleaning, potentially leaving parts inside the scope.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (foreign object retention in a medical device) where no injuries have been reported, fitting the 'High' severity criteria.

Plain-English summary

Medline Industries Inc is recalling single-use Endoscopic Cleaning Brushes sold in kits. The recall covers 183,606 devices distributed nationwide to 48 states and the District of Columbia. The affected products are identified by specific item numbers (DYK1002DCB, DYK1002DBDE, DYK1002DBSE, DYK1002SBC) and various finished good and kit lot numbers.

The recall was initiated because there is a potential risk of the brush detaching during the cleaning process. If the detachment is not identified, there is a potential for the brush to be left within the endoscope. The source text does not report any specific injuries, illnesses, or fatalities associated with this defect.

Healthcare facilities and consumers should stop using the affected endoscopic cleaning brushes immediately. Users should check their inventory for the specific item numbers and lot numbers listed in the official recall notice. For more information, contact Medline Industries Inc or refer to the FDA recall record Z-3210-2018.

The recalled product

Product
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
Manufacturer
Medline Industries Inc
Category
Medical Device — Endoscopic Accessories
Hazard
Affected units
183,606

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Endoscopic cleaning brush finished good lot numbers: GM10
  • GJ25
  • HA05
  • HA20. Kits: a. Item Number DYK1002DCB
  • kit Number (Kit Lot Number): DYK1001DCB (18BA0735)
  • DYK1002144B (18BA0644
  • 18DA0124)
  • DYK1008972E (18BA2199
  • 18DA1418
  • 18EAA023
  • 18EAA653)
  • DYK1012268E1 (18BA1667
  • 18CA0872
  • 18CA1289
  • 18DA1732)
  • DYK1012414E1 (18CA0793
  • 18CA1644
  • 18DA0413)
  • DYK1017922E (18CA1300)
  • DYK1018542E (18CA0622

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

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