Medline Industries, LP recalls Medline Convenience Kits: 1) CVC PACK
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 6) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 7) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 8) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 9) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 10) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 11) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 12) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 16) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 17) CHEST TUBE SUPPLIES, Model Number: DYKM2131
Lot / code information
- UDI
- 10653160327646(each), 653160327649(case)
- Lot #
- 2020121550; 2) DYKM1730A
- UDI
- 10193489111019(each), 20193489111016(case)
- Lot #
- 2024030690; 3) DYKM1730A
- UDI
- 10193489111019(each), 20193489111016(case)
- Lot #
- 2024052290; 4) DYKM1730A
- UDI
- 10193489111019(each), 20193489111016(case)
- Lot #
- 2024060590; 5) DYKM1730A
- UDI
- 10193489111019(each), 20193489111016(case)
- Lot #
- 2025012890; 6) DYKM1751A
- UDI
- 10193489111002(each), 20193489111009(case)
- Lot #
- 2023121190; 7) DYKM1756A
- UDI
- 10193489190250(each), 20193489190257(case)
- Lot #
- 2023060290; 8) DYKM1756A
- UDI
- 10193489190250(each), 20193489190257(case)
- Lot #
- 2023070590; 9) DYKM1756A
- UDI
- 10193489190250(each), 20193489190257(case)
- Lot #
- 2023111590; 10) DYKM1756A
- UDI
- 10193489190250(each), 20193489190257(case)
- Lot #
- 2023120590; 11) DYKM1756A
- UDI
- 10193489190250(each), 20193489190257(case)
- Lot #
- 2024022190; 12) DYKM1756A
- UDI
- 10193489190250(each), 20193489190257(case)
- Lot #
- 2024080190; 13) DYKM1756A
- UDI
- 10193489190250(each), 20193489190257(case)
- Lot #
- 2024101490; 14) DYKM1765A
- UDI
- 10193489190236(each), 20193489190233(case)
- Lot #
- 2023050490; 15) DYKM1765A
- UDI
- 10193489190236(each), 20193489190233(case)
- Lot #
- 2023071290; 16) DYKM1765A
- UDI
- 10193489190236(each), 20193489190233(case)
- Lot #
- 2024012490; 17) DYKM1765A
- UDI
- 10193489190236(each), 20193489190233(case)
- Lot #
- 2024071790; 18) DYKM1767B
- UDI
- 10193489112368(each), 20193489112365(case)
- Lot #
- 2023102790; 19) DYKM1776
- UDI
- 10888277733794(each), 20888277733791(case)
- Lot #
- 2024031590; 20) DYKM1776
- UDI
- 10888277733794(each), 20888277733791(case)
- Lot #
- 2025013190; 21) DYKM1781A
- UDI
- 10653160352730(each), 653160352733(case)
- Lot #
- 2024092390; 22) DYKM1783A
- UDI
- 10193489111330(each), 20193489111337(case)
- Lot #
- 2024053190; 23) DYKM1783A
- UDI
- 10193489111330(each), 20193489111337(case)
- Lot #
- 2024062890; 24) DYKM1783A
- UDI
- 10193489111330(each), 20193489111337(case)
- Lot #
- 2025011090; 25) DYKM1796A
- UDI
- 10653160354888(each), 653160354881(case)
- Lot #
- 2024041790; 26) DYKM1796A
- UDI
- 10653160354888(each), 653160354881(case)
- Lot #
- 2024061890; 27) DYKM1796A
- UDI
- 10653160354888(each), 653160354881(case)
- Lot #
- 2024072390; 28) DYKM1796A
- UDI
- 10653160354888(each), 653160354881(case)
- Lot #
- 2024093090; 29) DYKM1796A
- UDI
- 10653160354888(each), 653160354881(case)
- Lot #
- 2025010890; 30) DYKM1796A
- UDI
- 10653160354888(each), 653160354881(case)
- Lot #
- 2025020690; 31) DYKM1801B
- UDI
- 10653160360421(each), 653160360424(case)
- Lot #
- 2024011790; 32) DYKM1801B
- UDI
- 10653160360421(each), 653160360424(case)
- Lot #
- 2024062890; 33) DYKM1801B
- UDI
- 10653160360421(each), 653160360424(case)
- Lot #
- 2024100790; 34) DYKM1807
- UDI
- 10193489191219(each), 20193489191216(case)
- Lot #
- 2024032990; 35) DYKM1807
- UDI
- 10193489191219(each), 20193489191216(case)
- Lot #
- 2024071990; 36) DYKM1864
- UDI
- 10193489191257(each), 20193489191254(case)
- Lot #
- 2023101680; 37) DYKM1864
- UDI
- 10193489191257(each), 20193489191254(case)
- Lot #
- 2024010880; 38) DYKM1925
- UDI
- 10193489190311(each), 20193489190318(case)
- Lot #
- 2023112780; 39) DYKM1925
- UDI
- 10193489190311(each), 20193489190318(case)
- Lot #
- 2024040180; 40) DYKM1927A
- UDI
- 10193489199901(each), 20193489199908(case)
- Lot #
- 2023072590; 41) DYKM1927A
- UDI
- 10193489199901(each), 20193489199908(case)
- Lot #
- 2023080190; 42) DYKM1927A
- UDI
- 10193489199901(each), 20193489199908(case)
- Lot #
- 2023081490; 43) DYKM1927A
- UDI
- 10193489199901(each), 20193489199908(case)
- Lot #
- 2023121490; 44) DYKM1927A
- UDI
- 10193489199901(each), 20193489199908(case)
- Lot #
- 2024012590; 45) DYKM1977B
- UDI
- 10653160360797(each), 653160360790(case)
- Lot #
- 2023063090; 46) DYKM1977B
- UDI
- 10653160360797(each), 653160360790(case)
- Lot #
- 2023120890; 47) DYKM1977B
- UDI
- 10653160360797(each), 653160360790(case)
- Lot #
- 2024091290; 48) DYKM2131
- UDI
- 10195327058715(each), 40195327058716(case)
- Lot #
- 23ALA008
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What the firm is doing
An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers. 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, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 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 include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. 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 1/14/26 was sent to customers. 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-
DistributionShow detailsHide
Worldwide - US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2102-2026
- FDA device classification · LRPOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4800The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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