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Curativa Bay

Curativa Bay, LLC · Model WCHRX8 · UDI-DI 00860007709470

FRO Prescription

510(k) clearances

3,166

Adverse events (64 deaths)

Recalls

385

Facilities

Description

Rx INDICATIONS: The Prescription Use Curative Bay Wound Care Hydrogel Rx is indicated for the following uses: • Use with dermal irritation, sores, injuries and ulcers of dermal tissues. • Moistening and lubricating absorbent wound dressings and the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. • Management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.

Recalls

Date	Firm	Reason
2026-06-08	ConvaTec, Inc	Surgical dressing manufactured out of specification (greater thickness).
2026-04-27	Oculus 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
2026-01-16	Integra LifeSciences Corp. (NeuroSciences)	Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16	Integra LifeSciences Corp. (NeuroSciences)	Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16	Integra LifeSciences Corp. (NeuroSciences)	Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-05	Medline Industries, LP	Medline 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
2026-01-05	Medline Industries, LP	Medline 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
2025-08-05	Integra LifeSciences Corp. (NeuroSciences)	Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05	Integra LifeSciences Corp. (NeuroSciences)	Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05	Integra 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.