CODMAN 80-1449Recalls & reported problems
Cerenovus, Inc. · CODMAN Surgical Strips 1/8 Inch x 6 Inches (3mm x 152mm) · 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.
3 other recalls cover devices cleared under the same FDA submission (K880402); they may or may not involve this specific model.
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
- Sep 20, 2024Open, Classified
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Z-0248-2025 · Root cause: Nonconforming Material/Component · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K880402. One submission often covers many models, so check the product and lot details in each record.
- Z-0094-2011 · Jul 16, 2010 · TerminatedCodman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
- Z-0095-2011 · Jul 16, 2010 · TerminatedSurgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403
- Z-0093-2011 · Jul 16, 2010 · TerminatedCodman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396
Other NEUROSURGICAL PADDIE devices
- CODMAN® 801400Integra Lifesciences Production Corporation · Neurosurgical paddie2 recalls9 reports
- CODMAN® 801407Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall6 reports
- MEDLINE NEUROSPNG05Medline Industries, Inc. · Neurosurgical paddie1 recall5 reports
- CODMAN® 801451Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall5 reports
- CODMAN® 801404Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall4 reports
- CODMAN® 801406Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN® 801403Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN 80-1407Cerenovus, Inc. · NEUROSURGICAL PADDIE1 recall2 reports
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.
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