Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CAPSULOTOMY, Model Num
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 07, 2026 |
| Reported | February 25, 2026 |
| Recalling firm | Medline Industries, LP |
| Country / region | United States IL |
Hazard
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Product description
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 6) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 7) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 8) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 9) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 10) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 11) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 12) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 16) CVC PACK, Model Number: CVI4500A
Affected products
- Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB