Class IOngoingZ-2236-2026

Medline Industries, LP recalls Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection

Medline Industries, LPNorthfield, IL, United StatesReported Jun 3, 2026 · 3 months ago

Legal News Analyst · Jun 3, 2026

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline Kit SKU DYNJRA1212; 5) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1285; 6) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA9031; 7) SPINAL BLOCK TRAY 25G WHITACRE, Medline Kit SKU DYNJRA9032; 8) 25G SPINAL TRAY, Medline Kit SKU PAIN1239.

Lot / code information

Lot #: 26BBJ392; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case
Lot #: 26ABS354; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case
Lot #: 25LBC413; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case
Lot #: 25IBK142; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case
Lot #: 25FBD584; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case
Lot #: 25BBK828; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case
Lot #: 24FBT398; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case
Lot #: 24BBR608; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case
Lot #: 23JBB581; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case
Lot #: 23IBQ010; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case

What the firm 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 recalls@medline.com.

DistributionShow details

Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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