Z-1885-2026Class II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF...
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 GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D 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-1885-2026
- 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 GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
- Product code
- OHD Gynecological Laparoscopic Kit
- 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
- DYNJ909398A UDI-DI 10195327338190 (EA) 40195327338191 (CS) LOTS 24GMH510 24HMG886 DYNJ908706D UDI-DI 10198459017773 (EA) 40198459017774 (CS) LOTS 24HMA783 24HMG308 24KMC651 24KMJ274 24LME931 25AME217 25BMI653 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ909398A lots 23EMF078 23HME512 23HMI269 23JMB528 23KME175 24EMC327
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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