Z-1880-2026Class II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-27 / Open, Classified / root cause: design
Medline Industries, LP began a recall of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS... on . FDA classified it as Class II and gives the reason as "Unapproved design changes to the products outside of the 510(k) clearance". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1880-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
- Product code
- OGR Ear, Nose, And Throat Surgical Tray
- Reason for recall
- Unapproved design changes to the products outside of the 510(k) clearance.
- Root cause tag
- design
- FDA root cause
- Component change control
- Action
- On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
- Quantity in commerce
- 270,311 total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1876-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1877-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1878-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1879-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1880-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1881-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1882-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1883-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1884-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1885-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1886-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1887-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1888-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1889-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1890-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1891-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1892-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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