Recall Z-1885-2026
Medline Industries, LP · initiated February 27, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
Codes / 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
Reason for recall
Unapproved design changes to the products outside of the 510(k) clearance.
FDA-determined cause: Component change control
Action taken
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.
Details
- Recall number
- Z-1885-2026
- Initiated
- February 27, 2026
- Posted by FDA
- April 17, 2026
- Product code
- OHD – Gynecological Laparoscopic Kit
- Quantity
- 270,311 total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1876-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1877-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1878-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1879-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1880-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1881-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1882-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1883-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1884-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1886-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1887-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1888-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1889-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1890-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1891-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1892-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |