Recall Z-1881-2026 ยท FDE Laparoscopy Kit
Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599
| 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.