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MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU

FDA device recall Z-2749-2026 · posted 2026-07-22 · Open, Classified

Recall details

Recalling firm
Medline Industries, LP
Reason for recall
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Action taken
Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/5/2026 via USPS and email. The notice explained the issue, potential risk to health, and requested the following: identify and quarantine product, and complete response and return the response form using the Website link: https://recalls.medline.com. Those who further distributed the affected product have been directed to notify their customers. Upon receipt of the submitted response form, the consignee 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. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Root cause
Under Investigation by firm
Status
Open, Classified
Product code
OJH
Quantity affected
2301 kits
Distribution
US: OH, CA, IL, IN, FL, SC, AZ, NJ.
Date initiated
2026-06-05
Date posted
2026-07-22
Location
Northfield, IL

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