Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 28, 2012
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Supe…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Superstat Corp recalled Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For u… - a moderate-severity action.
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For u… was recalled by Superstat Corp in November 28, 2012. Reason: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to v…. Check the official notice for the remedy. Verify recall #Z-0338-2013 with the FDA Devices before acting.
The recall
Superstat Corp issued this moderate-severity FDA Devices recall-The recall was initiated because Superstat Corporation has confirmed that no documentation are available to v….
- Moderate
- severity level
- 26K units
- affected scope
- Class II
- classification
- November 28, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0338-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0338-2013) was formally reported on November 28, 2012, with the manufacturer initiating the action on October 24, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Superstat Corp is listed as the recalling firm, operating out of Rancho Dominguez, CA. Federal records list the affected scope as 26,422 units.
The documented reason for this recall is: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Spong… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.. 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
26,422 units
Related Recalls
6
3 from same agency
Product description
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Reason for recall
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0338-2013 |
| Date reported | November 28, 2012 |
| Date initiated | October 24, 2012 |
| Recalling firm | Superstat Corp |
| Firm location | Rancho Dominguez, CA |
| Affected scope | 26,422 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore. |
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-0338-2013) 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? ▼
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques. Recalled by Superstat Corp. Units affected: 26,422 units.
Why was this product recalled? ▼
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0338-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0338-2013) 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 28, 2012. 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.