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MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G recallZ-2747-2026 · Medline Industries, LP · initiated Jun 5, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected].

Recall details

Recall number
Z-2747-2026
Status
Open, Classified
Initiated by the company
Jun 5, 2026
Posted by the FDA
Jul 22, 2026
Recalling firm
Medline Industries, LP
Quantity
60 kits
Product code
LRO
FDA submissions
K213481
Distribution
US: OH, CA, IL, IN, FL, SC, AZ, NJ.

Product description

MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G

Code information (models, lots, serial numbers)

UDI/DI 10198459280559 (each) 40198459280550 (case), Lot Number 25DBF430

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

321 devices cleared under K213481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99290).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page