ConvaTec, Inc. is recalling approximately 240 Esteem Synergy Stomahesive Skin Barriers because the pre-cut wafer sizes inside the packaging do not match the product label. Affected packages labeled for 16mm or 35mm openings may actually contain a 28mm wafer. While no injuries have been reported, the company initiated this voluntary recall to prevent potential skin damage for ostomy patients.
If a wafer opening is too small and a user tries to apply it, the device can cause skin abrasions, cuts to the stoma, or bleeding. If the opening is too large, the device will not fit properly and cannot be used.
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Recall #: Z-0903-2025
Recall #: Z-0903-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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