Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 25, 2015
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.
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
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Tz Medical Inc. recalled SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part nu… - a moderate-severity action.
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part nu… was recalled by Tz Medical Inc. in November 25, 2015. Reason: During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in …. Check the official notice for the remedy. Verify recall #Z-0318-2016 with the FDA Devices before acting.
The recall
Tz Medical Inc. issued this moderate-severity FDA Devices recall-During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in ….
- Moderate
- severity level
- 10K units
- affected scope
- Class II
- classification
- November 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0318-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0318-2016) was formally reported on November 25, 2015, with the manufacturer initiating the action on October 14, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Tz Medical Inc. is listed as the recalling firm, operating out of Portland, OR. Federal records list the affected scope as 10,180 units.
The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10,180 units
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0318-2016 |
| Date reported | November 25, 2015 |
| Date initiated | October 14, 2015 |
| Recalling firm | Tz Medical Inc. |
| Firm location | Portland, OR |
| Affected scope | 10,180 units |
| Distribution | US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0318-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Tz Medical Inc.. Units affected: 10,180 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0318-2016.
Where was the recalled product distributed? ▼
Distribution: US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0318-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 25, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.