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ArmourSorb
AMERICAN SURGICAL COMPANY, LLC · Model 88-06 · UDI-DI 30749915002365
1
510(k) clearances
601
Adverse events
78
Recalls
29
Facilities
Description
ArmourSorb Ray-Cot 1/2" x 1/2" (13 mm x 13 mm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o |
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o |
| 2024-09-20 | Integra LifeSciences Corp. | 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 |
| 2024-09-20 | Integra LifeSciences Corp. | 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 |
| 2024-09-20 | Integra LifeSciences Corp. | 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 |
| 2024-09-20 | Integra LifeSciences Corp. | 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 |
| 2024-09-20 | Integra LifeSciences Corp. | 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 |
| 2024-09-20 | Integra LifeSciences Corp. | 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 |
| 2024-09-20 | Integra LifeSciences Corp. | 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 |
| 2024-09-20 | Integra LifeSciences Corp. | 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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.