Key facts
| Recalling firm | Medline Industries, LP |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026 |
| Classification | Class I |
| Recall number | Z-2235-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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. |
What this classification means
FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Medline Industries, LP and the affected product is described in FDA's record as: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026. FDA's stated reason for the recall is: 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.. The recall is tracked under FDA recall number Z-2235-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.
What consumers should do
Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026 -- and the recall number Z-2235-2026. If it matches, stop using or distributing it and contact Medline Industries, LP or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
Medline Industries, LP’s FDA history
Argus HQ has recorded 293 total FDA actions tied to Medline Industries, LP: 0 warning letters, 293 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- Has Medline Industries, LP had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 293 total FDA actions tied to Medline Industries, LP, including 293 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2235-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
Know if this happens again — we'll email you.
Free. No spam, just recall alerts for what you tell us to watch.
Related enforcement actions
Full FDA history for Medline Industries, LP- Recall: Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product… →
- Recall: Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product N… →
- Recall: Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Pro… →
- Recall: Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count,… →
- Recall: Medline Industries, LP — Class I recall: MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medlin… →
- Recall: Medline Industries, LP — Class II recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French size… →
- Recall: Medline Industries, LP — Class I recall: MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit… →
- Recall: Medline Industries, LP — Class I recall: MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G →
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class I Recall: Medline kits containing Huons Co. Bupivacaine HCL in… by Medline Industries, LP. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-medline-industries-lp-z-2235-2026
"FDA Recall Database: Class I Recall: Medline kits containing Huons Co. Bupivacaine HCL in… by Medline Industries, LP." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-medline-industries-lp-z-2235-2026.
Argus HQ Research. "FDA Recall Database: Class I Recall: Medline kits containing Huons Co. Bupivacaine HCL in… by Medline Industries, LP." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/recall/fda-recall-medline-industries-lp-z-2235-2026.
@misc{argushq_argushq_ai_recall_fda_recall_medline_industries_lp_z_2235_2026_2026,
title = {FDA Recall Database: Class I Recall: Medline kits containing Huons Co. Bupivacaine HCL in… by Medline Industries, LP},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-medline-industries-lp-z-2235-2026},
note = {Accessed: August 29, 2026}
}Source: FDA.gov — Recalls ↗

