Z-1879-2026Class II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK...
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 BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W... 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-1879-2026
- 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 BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
- Product code
- OFG Ct Biopsy 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
- DYNJ38587A UDI-DI 10193489754070 (EA) 40193489754071 (CS) LOTS 20BBF696 20EBH917 20FBW435 20HBM667 20JBF107 20KBW292 20LBS930 21EBB195 21FBR610 21GBS936 21GBS940 21JBU912 21KBP999 22ABX182 22EBI922 22GBZ788 22JBL031 23BBN160 DYNJ38587B UDI-DI 10195327397326 (EA) 40195327397327 (CS) LOTS 23DBP789 23FBM124 23HBW639 23JBN841 24ABG236 24CBM867 24FME120 24JMD066 24LME187 DYNJ30078D UDI-DI 10889942138647 (EA) 40889942138648 (CS) LOTS 23CBK546 23FBQ481 23IBQ435 23JBR634 23LBG856 24ABE287 24BBS264 24EBQ336 24GBJ987 24JBO830 DYNJ59108B UDI-DI 10198459138461 (EA) 40198459138462 (CS) LOT 24JBP861 ***Updated 5/20/26 - The following lots were included in the customer communication but not in the FDA submission.*** DYNJ30078D Lots 21EBD861 21IBM130 21IBV938 21IBV939 21IBV940 21LBB809 22ABZ810 22BBV614 22FBL865 22IBE477 22JBH508 22KBJ437 22OBC310 23BBT881 23EBK298; DYNJ38587B Lots 25BMB873; DYNJ59108B Lots 24LBT539
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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