Z-0189-2027Class II

Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A

Name: Z-0189-2027 Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Creator: Medline Industries, LP
Published: 2026-09-11
License: https://open.fda.gov/license/

Medline Industries, LP / initiated 2026-09-11 / Open, Classified

FDA source

Recall record

Recall number: Z-0189-2027
Classification: Class II
Status: Open, Classified
Initiated: 2026-09-11
Posted: 2026-10-15
Recalling firm: Medline Industries, LP
Product: Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Discrepancy in the shelf-life of a component
FDA root cause: Labeling Change Control
Action: Medline 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 [email protected].
Quantity in commerce: 30 kits
Distribution: US Nationwide distribution in the state of NY.
Product codes and lots: UDI/DI 10195327174156 (each) 40195327174157 (case), Lot Number 22GBW912

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0189-2027
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0189-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-15

Product code KCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)