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Medline kits containing Huons Co. Bupivacaine HCL in… recallZ-2231-2026 · Medline Industries, LP · initiated Apr 10, 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 kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

FDA root cause category: Component design/selection

What the company is doing

Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 4/10/2026 via USPS first class mail and email. The notice explained the issue with the component and requested the following: - Identify and quarantine the affected item and lot numbers (kit). - Respond to notice via the portal: Website link: https://recalls.medline.com, Recall Reference #: R-26-065-FGX1, using the Recall Code provided. - Once the response is received, over-labels will be provided to be placed on the affected inventory with instructions to remove and discard the affected component. - Distributors or those who have further distributed the product are directed to notify those to whom the affected kits were distributed and include the 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].

Recall details

Recall number
Z-2231-2026
Status
Open, Classified
Initiated by the company
Apr 10, 2026
Posted by the FDA
May 28, 2026
Recalling firm
Medline Industries, LP
Quantity
1100 kits
Product code
CAI
Distribution
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.

Product description

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.

Code information (models, lots, serial numbers)

Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26CBA272; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26ABS307; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25HBE663; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25FBA408; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25CBG043; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 24FBT395; Medline SKU DYNJRA2151: UDI/DI 10195327365400 each, FI case, Lot Numbers: 24FBT396.

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 98837).

Sources and updates

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