Design Options® 560621Recalls & reported problems
B. Braun Medical Inc. · Spinal Tray · Class 2
Data updated Oct 13, 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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. How this data works · Data updated Oct 13, 2026.
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-2278-2026 · Root cause: Under Investigation by firm · FDA record ↗
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® 560074B. Braun Medical Inc. · Spinal anesthesia kit1 recall1 report
- Design Options® 560533B. 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page