Recall record at a glance
| Official record | Z-2236-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Ongoing |
| Recalling firm | Medline Industries, LP |
| Report date | Jun 3, 2026 |
| Recall initiation date | Apr 10, 2026 |
| Quantity | 30120 kits |
| Location | Northfield, IL, United States |
Official product description
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.
Why the product 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.
Distribution information
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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