Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving unapproved design changes to a medical device. The source text does not report any illnesses, injuries, or deaths, and the hazard is regulatory non-compliance rather than an inherent safety defect with documented harm. Class II recalls without reported adverse events typically fall in the Moderate range.
Plain-English summary
Medline Industries, LP is recalling Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes. The affected products include Minor ENT Sinus Pack and Sinus Pack models with specific lot numbers identified by the manufacturer.
The recall was initiated because the products underwent design changes that were not approved through the FDA's 510(k) premarket notification process. These unapproved modifications fall outside the scope of the original device clearance.
The affected kits were distributed nationwide in the United States and internationally to Canada, Panama, and Barbados. A total of 270,311 units have been identified as part of this recall.
Consumers and healthcare facilities in possession of affected lots should discontinue use and contact Medline Industries for instructions on device return or replacement. The specific lot numbers and UDI codes are available in the FDA recall notice for identification purposes.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
- Manufacturer
- Medline Industries, LP
- Hazard
- unapproved-design-change
- regulatory-non-compliance
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 (2)
- DYNJ0101278G lots 23HDC100
- DYNJ0101278I lots 25AME306 25AMI354 25BMG147 25BMG147A
Distribution
Distributed nationwide across the United States.
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