Z-1887-2026Class II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY 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 EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY... 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-1887-2026
- 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 EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK DYNJ41250B
- Product code
- OJH Orthopedic 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
- DYNJ34846C UDI-DI 10193489781441 (EA) 40193489781442 (CS) LOT 24BBA459 DYNJ83218A UDI-DI 10195327382308 (EA) 40195327382309 (CS) LOT 24BBD199 DYNJ85396 UDI-DI 10195327497613 (EA) 40195327497614 (CS) LOT 24BBA503 DYNJ905156R UDI-DI 10198459017704 (EA) 40198459017705 (CS) LOTS 24HBG726 24JBJ484 25ABS758 25BBR196 25CBN174 25EBE136 DYNJ905159L UDI-DI 10195327664251 (EA) 40195327664252 (CS) LOT 24EMB726 DYNJ905159M UDI-DI 10198459017735 (EA) 40198459017736 (CS) LOT 24GMA714 24HMD401 24HMJ945 24JMD201 24KMG592 25AMC024 25BMD945 25CMG373 DYNJ69926A UDI-DI 10195327153601 (EA) 40195327153602 (CS) LOT 24ABS445 DYNJ41250B UDI-DI 10888277801257 (EA) 40888277801258 (CS) LOT 24ABO122 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ905156R lots 24GBD135 24IBK563 24IBS862 25BBH767
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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