Recall Z-1880-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-02-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262. Reason: Unapproved design changes to the products outside of the 510(k) clearance..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-27
- Firm location
- Northfield, IL, United States
Product description
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
Reason for recall
Unapproved design changes to the products outside of the 510(k) clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.