Getinge Disinfection Ab

FDA recalling firm · 5 enforcement events · 7 product records · 2014–2025 · N/A

Getinge Disinfection Ab has 5 FDA enforcement events on this register (7 product records) between 2014 and 2025: 5 device; the busiest year was 2025 with 2.

0% of its events are Class I; the most common class is Class II (4). 2 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
29 Aug 2025	Getinge 88-Series Washer- Disinfector. Model Number: 88-5.	Device	Class II	1	Ongoing
2 Apr 2025	Washer Disinfector Aquadis 56; Model Number: 56A	Device	Class II	2	Ongoing
2 Mar 2018	Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts)…	Device	Class II	2	Terminated
26 Jun 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.	Device	Class III	1	Terminated
26 Nov 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…	Device	Class II	1	Terminated

By type and class

Device5

Class II4

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Getinge Disinfection Ab by year initiated.

Questions and answers

How many FDA recalls has Getinge Disinfection Ab had?

5 enforcement events (7 product records) on this register, 2014–2025: 5 device.

Are any Getinge Disinfection Ab recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Getinge Disinfection Ab recalls?

4 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.