Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 31, 2014
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. Aft…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Getinge Disinfection Ab recalled GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Con… - a moderate-severity action.
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Con… was recalled by Getinge Disinfection Ab in December 31, 2014. Reason: Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and di…. Check the official notice for the remedy. Verify recall #Z-0852-2015 with the FDA Devices before acting.
The recall
Getinge Disinfection Ab issued this moderate-severity FDA Devices recall-Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and di….
- Moderate
- severity level
- Class II
- classification
- December 31, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0852-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0852-2015) was formally reported on December 31, 2014, with the manufacturer initiating the action on November 26, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Getinge Disinfection Ab is listed as the recalling firm, operating out of Vaxjo. Federal records list the affected scope as 551 total: USA: 547 units, Canada: 4 units.
The documented reason for this recall is: Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analys… Distribution data in the federal record shows the product reached: Distributed US (nationwide) and the country of Canada.. 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
551 total: USA: 547 units, Canada: 4 units
Related Recalls
6
3 from same agency
Product description
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Reason for recall
Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0852-2015 |
| Date reported | December 31, 2014 |
| Date initiated | November 26, 2014 |
| Recalling firm | Getinge Disinfection Ab |
| Firm location | Vaxjo |
| Affected scope | 551 total: USA: 547 units, Canada: 4 units |
| Distribution | Distributed US (nationwide) and the country of Canada. |
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-0852-2015) 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? ▼
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.. Recalled by Getinge Disinfection Ab. Units affected: 551 total: USA: 547 units, Canada: 4 units.
Why was this product recalled? ▼
Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2014. Severity: Moderate. Recall number: Z-0852-2015.
Where was the recalled product distributed? ▼
Distribution: Distributed US (nationwide) and the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0852-2015) 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 December 31, 2014. 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.