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
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-2231-2026
- 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 2026 | Recall initiated by company | |
| 28 May 2026 | Classified by FDA | +48 days |
| 3 Jun 2026 | Published 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: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.
Where it was distributed
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Questions about this recall
Is Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as recalled?
Yes. Medline Industries recalled Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as on 10 Apr 2026. The recall is Class I and its status is Ongoing. Recall number Z-2231-2026.
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 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.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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