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RenoCare Spot

T&L Co.,Ltd. · Model HD14EN46 · UDI-DI 08800048007731

NAD

510(k) clearances

18,954

Adverse events (8 deaths)

Recalls

515

Facilities

Description

RenoCareTM Hydrocolloid Band has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a breathable polyurethane film backing. Hydrocolloid matrix rapidly absorbs exudates to form a cohesive gel providing significantly higher absorbency than the leading competitive hydrocolloid. In addition to excellent absorbency, the breathable polyurethane film backing provides a consistently high rate of moisture vapor transmission. Together, these features ensure an optimal moist wound environment, minimize the chance for damage to healthy peri-wound skin and provide cost-effective wear time for up to seven days.

Recalls

Date	Firm	Reason
2025-08-29	ConvaTec, Inc	Wound dressing may have foreign matter on the product.
2025-02-19	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for the sterility of the device to be compromised.
2022-01-28	Sam Medical Products	Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered ov
2021-08-20	ConvaTec, Inc	Primary packaging labeling may be incorrect.
2021-08-09	ConvaTec, Inc	There is a potential for open seals which can compromise sterility.
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect

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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.