FDA Device recall Z-1880-2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DY…
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DY… by Medline Industries, citing unapproved design changes to the products outside of the 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1880-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-27 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
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.
Identifiers
| code_info | DYNJ0101278F UDI-DI 10193489352351 (EA) 40193489352352 (CS) LOTS 22CDB133 22EDA975 22FDA831 22HDC403 DYNJ…DYNJ0101278F UDI-DI 10193489352351 (EA) 40193489352352 (CS) LOTS 22CDB133 22EDA975 22FDA831 22HDC403 DYNJ0101278G UDI-DI 10195327286477 (EA) 40195327286478 (CS) LOTS 22KDB109 22LDA476 23CDA805 23DDB546 23EDC278 23FDC023 23JDA625 23KDB893 24ADB642 24BDB842 24CDB908 24GDA043 24IDA026 DYNJ0101278I UDI-DI 10198459119477 (EA) 40198459119478 (CS) LOT 24JDC169 DYNJ56262 UDI-DI 10889942624331 (EA) 40889942624332 (CS) LOT 24ABO125 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ0101278F lots 21ADC024 21CDA355 21EDA527 21GDC529 21IDA040 21IDA786 21JDB214 21KDC443 22ADC117 22GDA789; DYNJ0101278G lots 23HDC100; DYNJ0101278I lots 25AME306 25AMI354 25BMG147 25BMG147A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1880-2026%22
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