CLASS III Device recall · Reported 4 Mar 2020 · FDA Enforcement Report
Getinge 46-Series Washer Disinfector recalled
Maquet Cardiovascular Us Sales is recalling Getinge 46-Series Washer Disinfector, distributed in 7 states. The recall was initiated on 16 Jan 2020 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1391-2020
- FDA event ID
- 84885
- Recalling firm
- Maquet Cardiovascular Us Sales, Wayne, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Jan 2020
- FDA classified
- 27 Feb 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 16 Jan 2020 | Recall initiated by company | |
| 27 Feb 2020 | Classified by FDA | +42 days |
| 4 Mar 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Product as listed by the FDA
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Where it was distributed
U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
CaliforniaColoradoIowaMinnesotaNew YorkSouth CarolinaVirginia
Questions about this recall
Why was it recalled?
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Which lots are affected?
Serial Numbers: WAA090094, WAA090112, WAA090409, WAA090521, WAA090757, WAA090805, WAA091170, WAA091288, WAA091292, WAA091454, WAA091460 WAA091463, WAA091477. UDI Code 07340153700048
Where was it sold?
U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 84885This product is part of a recall event; the main page for the event is Getinge 46-Series Washer Disinfector recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Getinge 46-Series Washer Disinfector recalled | Maquet Cardiovascular Us Sales | Other | 7 states |
More recalls from Maquet Cardiovascular Us Sales
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|---|---|---|---|---|---|
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All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |