Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk
Medline Industries Inc is recalling 1,400 endoscopic cleaning brushes because the brush may detach during use. The recall covers specific models and lots distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk of harm (brush detachment) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries Inc is recalling 1,400 units of Endoscopic Cleaning Brushes. These single-use devices are intended to clean the interior of endoscopes after procedures by being threaded through the biopsy valve. The recall is due to a potential risk of the brush detaching during the cleaning process.
The affected products are Model# DYK1002DCB and DYK1002DBDE, with lot numbers GM10, GJ25, HA05, and HA20. The products were distributed nationwide, including in California, Indiana, and Ohio.
Healthcare facilities and consumers should stop using these specific brushes and contact Medline Industries Inc for further instructions or a refund.
The recalled product
- Product
- Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove…
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 1,400
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 (4)
- Model# : DYK1002DCB and DYK1002DBDE LOT #: GM10
- GJ25
- HA05
- and HA20
Distribution
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