Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 22, 2017
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged durin…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Advanced Sterilization Products recalled STERRAD NX Sterilization System, Product Code: 10033, 10033-002 - a moderate-severity action.
STERRAD NX Sterilization System, Product Code: 10033, 10033-002 was recalled by Advanced Sterilization Products in February 22, 2017. Reason: Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external …. Check the official notice for the remedy. Verify recall #Z-1197-2017 with the FDA Devices before acting.
The recall
Advanced Sterilization Products issued this moderate-severity FDA Devices recall-Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external ….
- Moderate
- severity level
- 8K units
- affected scope
- Class II
- classification
- February 22, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1197-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1197-2017) was formally reported on February 22, 2017, with the manufacturer initiating the action on January 9, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Advanced Sterilization Products is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 7,694 units total (5,935 units in US).
The documented reason for this recall is: Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Australia, China, Hong Kong, India, Indonesia, Korea (South), Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan, T…. 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
7,694 units total (5,935 units in US)
Related Recalls
6
3 from same agency
Product description
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Reason for recall
Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1197-2017 |
| Date reported | February 22, 2017 |
| Date initiated | January 9, 2017 |
| Recalling firm | Advanced Sterilization Products |
| Firm location | Irvine, CA |
| Affected scope | 7,694 units total (5,935 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Australia, China, Hong Kong, India, Indonesia, Korea (South), Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam, 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-1197-2017) 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? ▼
STERRAD NX Sterilization System, Product Code: 10033, 10033-002. Recalled by Advanced Sterilization Products. Units affected: 7,694 units total (5,935 units in US).
Why was this product recalled? ▼
Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1197-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Australia, China, Hong Kong, India, Indonesia, Korea (South), Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam, Canada, Belgium, Czech Republic, Egypt, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, Japan, Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1197-2017) 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 February 22, 2017. 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.