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DeRoyal
DEROYAL INDUSTRIES, INC. · Model 30-154-EG · UDI-DI 00749756966764
EFQ
Prescription
10
510(k) clearances
292
Adverse events (2 deaths)
13
Recalls
57
Facilities
Description
Neuro Sponges
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-08 | AMD Medicom Inc. | Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet end |
| 2026-05-08 | AMD Medicom Inc. | Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet end |
| 2026-05-07 | TELEFLEX LLC | Due to out-of-specification, or potential out-of-specification, levels of endotoxins |
| 2022-09-28 | TELEFLEX LLC | Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised. |
| 2022-03-22 | Steris Corporation | Product not approved for release for US distribution |
| 2022-03-22 | Steris Corporation | Product not approved for release for US distribution |
| 2020-11-09 | ROi CPS LLC | Gauze sponges contained in custom kits may be flaking or fraying. |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
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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.