Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported September 21, 2022
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Product contains incorrect chemical indicators in packaging.
Steris Corporation Hopkins Facility recalled Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterili… - a low-severity action.
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterili… was recalled by Steris Corporation Hopkins Facility in September 21, 2022. Reason: Product contains incorrect chemical indicators in packaging.. Check the official notice for the remedy. Verify recall #Z-1736-2022 with the FDA Devices before acting.
The recall
Steris Corporation Hopkins Facility issued this low-severity FDA Devices recall-Product contains incorrect chemical indicators in packaging..
- Low
- severity level
- Class III
- classification
- September 21, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1736-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1736-2022) was formally reported on September 21, 2022, with the manufacturer initiating the action on August 10, 2022. It is classified under Low severity (Class III), with a current status of Terminated. Steris Corporation Hopkins Facility is listed as the recalling firm, operating out of Mentor, OH. Federal records list the affected scope as 619 boxes.
The documented reason for this recall is: Product contains incorrect chemical indicators in packaging. Distribution data in the federal record shows the product reached: Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
619 boxes
Related Recalls
6
3 from same agency
Product description
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Reason for recall
Product contains incorrect chemical indicators in packaging.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1736-2022 |
| Date reported | September 21, 2022 |
| Date initiated | August 10, 2022 |
| Recalling firm | Steris Corporation Hopkins Facility |
| Firm location | Mentor, OH |
| Affected scope | 619 boxes |
| Distribution | Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY |
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-1736-2022) 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? ▼
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.. Recalled by Steris Corporation Hopkins Facility. Units affected: 619 boxes.
Why was this product recalled? ▼
Product contains incorrect chemical indicators in packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Low. Recall number: Z-1736-2022.
Where was the recalled product distributed? ▼
Distribution: Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1736-2022) 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 September 21, 2022. 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.