Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 19, 2012
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resul…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Steris Corporation recalled The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Proce… - a moderate-severity action.
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Proce… was recalled by Steris Corporation in September 19, 2012. Reason: The firm initiated a recall after complaint investigations revealed that when the units are left on and not i…. Check the official notice for the remedy. Verify recall #Z-2335-2012 with the FDA Devices before acting.
The recall
Steris Corporation issued this moderate-severity FDA Devices recall-The firm initiated a recall after complaint investigations revealed that when the units are left on and not i….
- Moderate
- severity level
- 6K units
- affected scope
- Class II
- classification
- September 19, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2335-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2335-2012) was formally reported on September 19, 2012, with the manufacturer initiating the action on August 1, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Steris Corporation is listed as the recalling firm, operating out of Mentor, OH. Federal records list the affected scope as 6,051 units.
The documented reason for this recall is: The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause dam… Distribution data in the federal record shows the product reached: Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.. 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
6,051 units
Related Recalls
6
3 from same agency
Product description
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Reason for recall
The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2335-2012 |
| Date reported | September 19, 2012 |
| Date initiated | August 1, 2012 |
| Recalling firm | Steris Corporation |
| Firm location | Mentor, OH |
| Affected scope | 6,051 units |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong. |
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-2335-2012) 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? ▼
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.. Recalled by Steris Corporation. Units affected: 6,051 units.
Why was this product recalled? ▼
The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 19, 2012. Severity: Moderate. Recall number: Z-2335-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2335-2012) 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 19, 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.