Food, drugs, devices › Getinge Disinfection Ab
Device recall: Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare f
Getinge Disinfection Ab (Vaxjo) initiated this device recall on 26 Jun 2015; FDA lists 1 product record under event 71777, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 23 May 2018. Initiation: voluntary: firm initiated. Getinge Disinfection Ab has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Getinge Disinfection Ab, Vaxjo, Sweden.
Reason for recall
"Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network."
Distribution
"Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2419-2015 | Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes. | 20 devices | Class III | Terminated | 26 Aug 2015 |
Context
Other enforcement events for Getinge Disinfection Ab
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Aug 2025 | Getinge 88-Series Washer- Disinfector. Model Number: 88-5. | Device | Class II | 1 |
| 2 Apr 2025 | Washer Disinfector Aquadis 56; Model Number: 56A | Device | Class II | 2 |
| 2 Mar 2018 | Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 0734015370 | Device | Class II | 2 |
| 26 Nov 2014 | GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Clas | Device | Class II | 1 |
All 5 events for Getinge Disinfection Ab
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 May 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.