CLASS II Device recall · Reported 1 Aug 2012 · FDA Enforcement Report
Getinge -- large capacity, floor loading jet spray recalled
Getinge USA is recalling Getinge -- large capacity, floor loading jet spray, washers for mechanical washing, distributed in Indiana, Kansas, Maryland, New Mexico, Texas. The recall was initiated on 25 May 2012 and the FDA has classified it as Class II.
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-2079-2012
- FDA event ID
- 61974
- Recalling firm
- Getinge USA, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 May 2012
- FDA classified
- 26 Jul 2012
- Reported
- 1 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 25 May 2012 | Recall initiated by company | |
| 26 Jul 2012 | Classified by FDA | +62 days |
| 1 Aug 2012 | 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
Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
Where it was distributed
Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada
Questions about this recall
Is Getinge -- large capacity, floor loading jet spray, washers for mechanical washing recalled?
Yes. Getinge USA recalled Getinge -- large capacity, floor loading jet spray, washers for mechanical washing on 25 May 2012. The recall is Class II and its status is Terminated. Recall number Z-2079-2012.
Why was it recalled?
Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.
Which lots are affected?
Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952
Where was it sold?
Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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