Recall Z-1889-2026 ยท KKX Drape, Surgical, Antimicrobial
Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
| 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
| K020393 | MASTER & FRANK SURGICAL DRAPES (STERILE) Master & Frank Enterprses Co., Ltd., May 3, 2002 |