Recall record at a glance
| Official record | Z-2233-2026 |
|---|---|
| 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 | 41720 kits |
| Location | Northfield, IL, United States |
Official 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.
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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