Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk
Medline Industries is recalling endoscopic cleaning brushes because they may detach during use, potentially leaving parts inside endoscopes.
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) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries Inc is recalling 22,204 units of endoscopic cleaning brushes sold in various endoscopy kits. The brushes are used to clean endoscopes between patient procedures. The recall covers specific kit numbers (DYK1002DBDE, DYK1002DBSE, DYK1002DCB, and DYK1002SBC) and lot numbers (GM10, GJ25, HA05, and HA20).
The recall is due to a potential risk of the brush detaching during the cleaning process. If the detachment is not identified, there is a risk that the brush could be left inside the endoscope. The FDA has classified this as a Class II recall.
The affected products were distributed nationwide 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. Healthcare facilities and consumers should stop using the affected brushes and contact Medline Industries for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Medline Industries Inc
- Affected units
- 22,204
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 (7)
- KIT NUMBERS: DYK1002DBDE
- DYK1002DBSE
- DYK1002DCB
- and DYK1002SBC. LOT NUMBERS: GM10
- GJ25
- HA05
- and HA20
Distribution
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