Spinocan® 333211Recalls & reported problems
B. Braun Medical Inc. · Spinocan® 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) · Class 2
All models of Spinocan (7)
Data updated Oct 16, 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 04046964179389), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 2026.
Reports received per month
Recalls naming this device
- May 6, 2026Open, Classified
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Z-2277-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION. ITEM FOUND IN SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345397 ↗
Other Spinal anesthesia kit devices
- PENCAN® 333851B. Braun Medical Inc. · Spinal anesthesia kit1 recall45 reports
- PENCAN® 333868B. Braun Medical Inc. · Spinal anesthesia kit1 recall17 reports
- Design Options® 560603B. Braun Medical Inc. · Spinal anesthesia kit1 recall5 reports
- PENCAN® 333865B. Braun Medical Inc. · Spinal anesthesia kit1 recall4 reports
- PENCAN® 333871B. Braun Medical Inc. · Spinal anesthesia kit1 recall2 reports
- Design Options® 560646B. Braun Medical Inc. · Spinal anesthesia kit1 recall1 report
- Design Options® 560074B. Braun Medical Inc. · Spinal anesthesia kit1 recall1 report
- Design Options® 560606B. Braun Medical Inc. · Spinal anesthesia kit1 recall1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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