Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 3, 2013
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Kimberly-Clark Corporation recalled KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. … - a moderate-severity action.
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. … was recalled by Kimberly-Clark Corporation in April 3, 2013. Reason: Some individual container filter units might contain thin areas that may potentially compromise the ability o…. Check the official notice for the remedy. Verify recall #Z-0995-2013 with the FDA Devices before acting.
The recall
Kimberly-Clark Corporation issued this moderate-severity FDA Devices recall-Some individual container filter units might contain thin areas that may potentially compromise the ability o….
- Moderate
- severity level
- Class II
- classification
- April 3, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0995-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0995-2013) was formally reported on April 3, 2013, with the manufacturer initiating the action on March 6, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Kimberly-Clark Corporation is listed as the recalling firm, operating out of Roswell, GA. Federal records list the affected scope as Code 68507 - 6420 cases; Code 68509 - 1281 cases.
The documented reason for this recall is: Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. Distribution data in the federal record shows the product reached: Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countrie…. 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
Code 68507 - 6420 cases; Code 68509 - 1281 cases
Related Recalls
6
3 from same agency
Product description
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
Reason for recall
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0995-2013 |
| Date reported | April 3, 2013 |
| Date initiated | March 6, 2013 |
| Recalling firm | Kimberly-Clark Corporation |
| Firm location | Roswell, GA |
| Affected scope | Code 68507 - 6420 cases; Code 68509 - 1281 cases |
| Distribution | Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Austral… |
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-0995-2013) 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? ▼
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.. Recalled by Kimberly-Clark Corporation. Units affected: Code 68507 - 6420 cases; Code 68509 - 1281 cases.
Why was this product recalled? ▼
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-0995-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, Belgium, Hong Kong, Japan, Portugal, and Singapore..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0995-2013) 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.
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 April 3, 2013. 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.