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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmSeptember 11, 2026
Date PostedOctober 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0189-2027
Recall Event ID 99983
Product Classification Tourniquet, pneumatic - Product Code KCY
ProductMedline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Code Information UDI/DI 10195327174156 (each) 40195327174157 (case), Lot Number 22GBW912
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
866-359-1704
Manufacturer Reason
for Recall		Discrepancy in the shelf-life of a component
FDA Determined
Cause 2		Labeling Change Control
ActionMedline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 9/11/2026 via email and USPS First Class Mail. The letter 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. 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-26-223-FGX2 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.
Quantity in Commerce30 kits
DistributionUS Nationwide distribution in the state of NY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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