Class I Recall

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POIN

Summary

The FDA issued a Class I for Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la by Medline Industries, LP. Reason: Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality is.

Details

Source

Device Recall

External ID

Z-2233-2026

Action Date

2026-06-03

Status

Ongoing

Product Description

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.

Lot/Code Info: Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMH714; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMF179; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25IMI476; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25GME934; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24JMA156; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24IMG162; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23IBG784; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBG512; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBA325; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 26AMK307; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25LME383; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25JMJ632; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMI508; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMB093; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25GMB270; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMD040; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMB958; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMD548; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMA551; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24GMI471; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24DBA515; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24BBQ043; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23IBH382; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23GBD403; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 26BMH362; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25LMC760; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25JME361; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25IMI413; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMH140; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMA304; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25GMB268; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25FMF696; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25DMJ266; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB245; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB241; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24GMB114; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24BME560; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25KMD376; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25JMC383; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25FMH538; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24KDB290; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24EDB889; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 23JDC308; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 26ABW292; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25KBT852; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25JBR203; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBS729; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBJ284; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25EBD163; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24EDB670; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24CDA047; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24BDA117; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 23JDB931; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26BBN630; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26BBN631; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABU477; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABU479; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABQ765; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABE062; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABE063; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE494; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE495; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE493; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25BBC565; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 24BBP041; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23HBS638; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23HBS639; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23GBC535; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 26ABQ980; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 26ABJ386; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25LBH067; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25KBR359; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25JBP383; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25IBK145; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25ABP041; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24GBD227; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24FBJ511; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24FBJ026; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24BBP046; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 23IBG977; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 23GBM182.

Quantity Affected: 41720 kits

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.

Distribution

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

Type: Voluntary: Firm initiated

Recall Initiated: 2026-04-10

Company

Medline Industries, LP

Northfield, IL

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 129 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medline Industries, LP have FDA actions?

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2233-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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