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MEDLINE medical procedure convenience kit labeled as:… recallZ-2764-2026 · Medline Industries, LP · initiated Jun 8, 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

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Medline Industries, LP issued an URGENT MEDICAL DEVCIE RECALL notice to its consignees on 6/8/2026 via email and USPS first class mail. The notice explained the issue and requested the following actions be taken: 1. Check stock and quarantine all affected product. 2. Use Website link: https://recalls.medline.com to respond. 3. Once response is received, Medline will send over-labels to affix to affected inventory (if applicable). 4. If the consignee further distributed or transferred the affected product, those to whom the product was sent are to be notified. For questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-2764-2026
Status
Open, Classified
Initiated by the company
Jun 8, 2026
Posted by the FDA
Jul 23, 2026
Recalling firm
Medline Industries, LP
Quantity
52 kits
Product code
LRO
FDA submissions
K213481
Distribution
US: Mo, CO, IL

Product description

MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N

Code information (models, lots, serial numbers)

UDI/DI 10198459266621 (each) 40198459266622 (case), Lot Numbers: 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, 25GDA213.

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 99297).

Sources and updates

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