SilverStat — Class II medical device recall Z-0318-2016
Terminated recall by TZ Medical Inc., reported 2015-11-25, distributed in AL, AR, CA, DC, FL, GA, IA, MD…. During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in t
| Recall number | Z-0318-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TZ Medical Inc., Portland, OR, United States |
| Recall initiated | 2015-10-14 |
| Classified | 2015-11-18 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-10-24 |
| Distributed | AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, WV |
| Quantity | 10,180 units |
Product
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.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0318-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.