RecallDepth

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

Recall Initiated
January 7, 2026
Posted
February 17, 2026
Recall Number
Z-1400-2026
Quantity
1496 units
Firm Location
Northfield, IL

Reason for Recall

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.

Distribution

Worldwide distribution - US Nationwide.

Lot / Code Info

1) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024100790; 2) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2025013190; 3) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024071790; 4) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024072390; 5) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024080190; 6) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024101490; 7) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2025010890; 8) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2025011090; 9) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2025012890; 10) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2025020690; 11) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2024012590; 12) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024030690; 13) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024041790; 14) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024052290; 15) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024053190; 16) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024060590; 17) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024061890; 18) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024062890; 19) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024071990; 20) DYKM1781A, UDI-DI: 10653160352730(each), 00653160352733(case), Lot Number: 2024092390; 21) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024093090; 22) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2024091290; 23) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024012490; 24) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024022190; 25) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023120590; 26) DYKM1751A, UDI-DI: 10193489111002(each), 20193489111009(case), Lot Number: 2023121190; 27) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023121490; 28) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2024031590; 29) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2024010880; 30) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023070590; 31) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023071290; 32) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023111590; 33) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2023120890; 34) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024011790; 35) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024062890; 36) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2024040180; 37) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023072590; 38) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023080190; 39) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023081490; 40) DYKM1767B, UDI-DI: 10193489112368(each), 20193489112365(case), Lot Number: 2023102790; 41) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2023101680; 42) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2023063090; 43) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2023112780; 44) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023050490; 45) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023060290; 46) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024032990; 47) CVI4500A, UDI-DI: 10653160327646(each), 00653160327649(case), Lot Number: 2020121550

Root Cause

Under Investigation by firm

Action Taken

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-003 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form,