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CELOX Granules

MEDTRADE PRODUCTS LIMITED · Model FG08830441 · UDI-DI 15060206630656

FRO
10
510(k) clearances
3,166
Adverse events (64 deaths)
82
Recalls
383
Facilities

Description

Hemostatic Granules: the device is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions. The device is for temporary external use only.

Recalls

DateFirmReason
2026-06-08ConvaTec, IncSurgical dressing manufactured out of specification (greater thickness).
2026-04-27Oculus Technologies of Mexico, S.A. de C.V.The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the produc
2026-01-16Integra LifeSciences Corp. (NeuroSciences)Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16Integra LifeSciences Corp. (NeuroSciences)Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16Integra LifeSciences Corp. (NeuroSciences)Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-05Medline Industries, LPMedline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for
2026-01-05Medline Industries, LPMedline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for
2025-08-05Integra LifeSciences Corp. (NeuroSciences)Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05Integra LifeSciences Corp. (NeuroSciences)Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05Integra LifeSciences Corp. (NeuroSciences)Packaging failures were identified which could lead to a breach in the sterile barrier.

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Data 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.