Custodiol(R) 10 x 500 mlRecalls & reported problems
Dr. Franz Köhler Chemie GmbH · 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
- 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jan 9, 2024Class IIOpen, Classified
Potential for particles to be present in solution.
Z-3300-2024 · Root cause: Device Design · Recall details · FDA record ↗
Other System, Perfusion, Kidney devices
- KidneyVault PRGNX-8008-001Paragonix Technologies Inc · System, Perfusion, Kidney1 recall2 reports
- Belzer UW Cold Storage Solution BUW-500Preservation Solutions Inc · System, Perfusion, Kidney1 recall0 reports
- Belzer UW Cold Storage Solution BUW-002Preservation Solutions Inc · System, Perfusion, Kidney1 recall0 reports
- Waters IGL Cold Storage Solution CSS/2000/USPreservation Solutions Inc · System, Perfusion, Kidney1 recall0 reports
- EasiSlush BTLE-1250Bridge To Life Ltd. · System, Perfusion, Kidney1 recall0 reports
- LifePort® Kidney Transporter LKT101POrgan Recovery Systems, Inc. · System, Perfusion, Kidney3 reports
- Perfadex with THAM 19018Xvivo Perfusion AB · System, Perfusion, Kidney1 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
- 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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