Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SilverStat Recalled by TZ Medical Inc. Due to During a review of the IFU of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact TZ Medical Inc. directly.
Affected Products
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.
Quantity: 10,180 units
Why Was This Recalled?
During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k
Where Was This Sold?
This product was distributed to 18 states: AL, AR, CA, FL, GA, IA, MD, NE, NH, NC, PA, RI, SC, TN, TX, UT, WV, DC
About TZ Medical Inc.
TZ Medical Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report