Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 14, 2018
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
The sterilization process used was unqualified.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Safe N Simple, LLC recalled Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS… - a moderate-severity action.
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS… was recalled by Safe N Simple, LLC in November 14, 2018. Reason: The sterilization process used was unqualified.. Check the official notice for the remedy. Verify recall #Z-0400-2019 with the FDA Devices before acting.
The recall
Safe N Simple, LLC issued this moderate-severity FDA Devices recall-The sterilization process used was unqualified..
- Moderate
- severity level
- Class II
- classification
- November 14, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0400-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0400-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on August 22, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Safe N Simple, LLC is listed as the recalling firm, operating out of Clarkston, MI. Federal records list the affected scope as 104 cases.
The documented reason for this recall is: The sterilization process used was unqualified. Distribution data in the federal record shows the product reached: CA. 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 - 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 - 40,422 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
104 cases
Related Recalls
6
0 from same agency
Product description
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Reason for recall
The sterilization process used was unqualified.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0400-2019 |
| Date reported | November 14, 2018 |
| Date initiated | August 22, 2018 |
| Recalling firm | Safe N Simple, LLC |
| Firm location | Clarkston, MI |
| Affected scope | 104 cases |
| Distribution | CA |
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-0400-2019) 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? ▼
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315. Recalled by Safe N Simple, LLC. Units affected: 104 cases.
Why was this product recalled? ▼
The sterilization process used was unqualified.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0400-2019.
Where was the recalled product distributed? ▼
Distribution: CA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0400-2019) 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.
Nearby Recalls in This Category
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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 14, 2018. 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.