Cook G03978Recalls & reported problems
Cook Incorporated · Chiba Biopsy Needle · Class 1
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
- Mar 1, 2024Open, Classified
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1525-2024 · Root cause: Under Investigation by firm · FDA record ↗
Other DEVICE, PERCUTANEOUS, BIOPSY devices
- Cook G00012Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall2 reports
- Cook G03314Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G01559Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G04338Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00013Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00852Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G05040Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00850Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.