Medline Industries, Inc. DYNJRA9028Recalls & reported problems
Medline Industries, Inc. · SPINAL BLOCK 25G WHTCRE 5S BU · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884389285701), received between Apr 14, 2025 and Apr 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Lack of Effect” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Apr 10, 2026Class IOpen, Classified
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.
Z-2233-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Lack of Effect1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2025Lack of Effect
MEDLINE SPINAL BLOCK 25G WHT 5S "KIT" - BU ITEM#: (B)(6) THAT CONTAINS: BUPIVACAINE HYDROCHLORIDE IN 8.25% DEXTROSE INJECTION, USP SPINAL 0.75% NDC: 73293-0002-02. THE ADMINISTERING SURGEON REPORTS THAT THE BUPIVACAINE WAS NOT EFFECTIVE DURING SPINAL BLOCK. I ATTEMPTED TO REPORT TO MEDLINE, WHO WOULD NOT ACCEPT THE REPORT. I DID REACH OUT TO THE MANUFACTURER OF THE BUPIVACAINE HUONS BUT HAVE NOT YET RECEIVED A REPLY.
Patient problems: Insufficient Information
MAUDE report 21834542 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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