Recall Z-1885-2026 ยท OHD Gynecological Laparoscopic Kit
Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
| Date | Apr 17, 2026 (initiated Feb 27, 2026) |
| Status | Open, Classified |
| Reason | Unapproved design changes to the products outside of the 510(k) clearance. |
| 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 | 270,311 total |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.