SpinocanRecalls & reported problems across all models
B. Braun Medical Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Spinocan model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 7 models of Spinocan by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2018 and Sep 29, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (7 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Spinocan recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 3 of these models · Recall details · FDA record ↗
Most reported Spinocan problems
Device problems
- Contamination /Decontamination Problem7
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Spinocan models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Spinocan® 333211Spinal anesthesia kit1 recall1 report
- Spinocan® 333201Spinal anesthesia kit1 recall0 reports
- Spinocan® 333231Spinal anesthesia kit1 recall0 reports
- Spinocan® 333320NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)4 reports
- Spinocan® 333313NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- Spinocan® 333214Spinal anesthesia kit1 report
- Spinocan® 333290NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
Recent Spinocan adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Contamination /Decontamination Problem
This report has been identified as B. Braun Medical internal number (b)(4).As reported by the user facility:It was reported that the needles have a green substance on the hub. No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928062 ↗MalfunctionSep 29, 2026Contamination /Decontamination Problem
This report has been identified as B. Braun Medical internal number (b)(4).As reported by the user facility:It was reported that the needles have a green substance on the hub. No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928058 ↗MalfunctionSep 14, 2026Contamination /Decontamination Problem
As reported by the user facility:The needle used during a procedure had a residue on the top where the stylet is. No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50751306 ↗MalfunctionJun 30, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: THERE IS A GREEN FILM OR "GOO" WHICH IS CAUSING THE HUB TO STICK TO THE CANNULA WHEN DOING INJECTIONS AND GOING TO WITHDRAWAL THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25665730 ↗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 ↗MalfunctionMay 5, 2023Break; Break
AS REPORTED BY THE USER FACILITY: INSERTED THE CATHETER THROUGH THE INDUCER, IT DID NOT DO WHAT IT WAS SUPPOSED TO DO AND WHEN HE PULLED BACK THE TIP OF THE CATHETER WAS GONE. PATIENT HAD A SURGICAL PROCEDURE WITH A SMALL INCISION TO PULL OUT THE CATHETER PIECE. NO INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 16875471 ↗MalfunctionNov 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: DESCRIPTION OF ISSUE: BLACK, STICKY SUBSTANCE NOTED ON THE INSIDE OF 2 NEEDLES. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9295124 ↗MalfunctionNov 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: DESCRIPTION OF ISSUE: BLACK, STICKY SUBSTANCE NOTED ON THE INSIDE OF 2 NEEDLES. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9295123 ↗MalfunctionNov 27, 2018Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL): BROKEN/ NEEDLE
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8106123 ↗
Other B. Braun Medical Inc. products
- Infusomat54 models · 2,783 reports · 30 recalls
- IV Administration Set153 models · 281 reports · 68 recalls
- Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
- Outlook25 models · 195 reports · 24 recalls
- Perifix57 models · 224 reports · 20 recalls
- Extension Set41 models · 101 reports · 16 recalls
- Design Options116 models · 132 reports · 14 recalls
- Blood Administration Set24 models · 177 reports · 13 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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