Medline Industries, LP recalls Medline medical convenience kits
Reason for recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
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.
Affected products & lots
- Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKUDYNJ36478BAffected lot26CMC977
What the firm is doing
Medline Industries, LP issued an URGENT MEDICAL DEVICE notice to its consignees on 3/24/2026 via email and mail. The notice explained the issue, potential risk and requested the following: "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-26-046 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." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
DistributionShow detailsHide
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2146-2026
- FDA device classification · OGROfficial FDA classification for this device type
- CFR regulation · 21 CFR 874.4420The 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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