CLASS I ONGOING Device recall · Reported 3 Jun 2026 · FDA Enforcement Report

Medline kits containing Huons Co. Bupivacaine HCL recalled

Medline Industries is recalling Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as, distributed nationwide in the US. The recall was initiated on 10 Apr 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesMedline Kit SKU DYNJRA9026: UDI/DI 10884389285688 each, 40884389285689, case, Lot Numbers: 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, 24FBJ505.
Quantity recalled4370 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2235-2026
FDA event ID
98837
Recalling firm
Medline Industries, Northfield, IL
Classification
Class I
Status
Ongoing
Recall initiated
10 Apr 2026
FDA classified
28 May 2026
Reported
3 Jun 2026
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons
Device type
Spinal Implants

Timeline

10 Apr 2026Recall initiated by company
28 May 2026Classified by FDA+48 days
3 Jun 2026Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026

Where it was distributed

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

Nationwide

Questions about this recall

Why was it 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.

Which lots are affected?

Medline Kit SKU DYNJRA9026: UDI/DI 10884389285688 each, 40884389285689, case, Lot Numbers: 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, 24FBJ505.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 98837

This product is part of a recall event; the main page for the event is Medline kits containing Huons Co. Bupivacaine HCL recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IMedline kits containing Huons Co. Bupivacaine HCL recalledMedline IndustriesOtherNationwide
CLASS IMedline kits containing Huons Co. Bupivacaine HCL recalledMedline IndustriesOtherNationwide
CLASS IMedline kits containing Huons Co. Bupivacaine HCL recalledMedline IndustriesOtherNationwide
CLASS IMedline kits containing Huons Co. Bupivacaine HCL recalledMedline IndustriesOtherNationwide
CLASS IMedline kits containing Huons Co. Bupivacaine HCL recalledMedline IndustriesOtherNationwide
CLASS IMedline kits containing Huons Co. Bupivacaine HCL recalledMedline IndustriesOtherNationwide

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