Recall Register

Getinge Usa Sales Inc: FDA recalls

FDA enforcement reports name Getinge Usa Sales Inc as the recalling firm in 17 events. The events have 48 product records. The recalls started from 2021 to 2025. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

17 events, newest first.

FDA enforcement events of Getinge Usa Sales Inc
InitiatedProduct (first record)TypeClassRecordsStatus
15 Jan 2025Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.DeviceClass I1Ongoing
3 Oct 2024MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0DeviceClass II8Ongoing
29 May 2024ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4DeviceClass II3Ongoing
1 May 2024Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.DeviceClass I1Ongoing
11 Dec 2023Flow-i C20 Anesthesia System, model 6677200DeviceClass II5Ongoing
8 Nov 2023Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT629109A, PWDII50SF - ARDPWT629110A,…DeviceClass II15Ongoing
6 Sep 2023Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2DeviceClass II1Ongoing
22 Dec 2022Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400DeviceClass I3Ongoing
7 Nov 2022Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)DeviceClass II1Ongoing
14 Oct 2022Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20ANDeviceClass II1Ongoing
21 Jul 2022Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)DeviceClass II1Ongoing
20 Jul 2022Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000DeviceClass I1Ongoing
6 May 2022VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DFDeviceClass II1Ongoing
2 May 2022Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700DeviceClass I2Terminated
13 Apr 2022Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WUDeviceClass II2Ongoing
1 Apr 2022Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.DeviceClass II1Ongoing
9 Dec 2021Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624…DeviceClass I1Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Getinge Usa Sales Inc: events for each product type
TypeEvents
Device17
Getinge Usa Sales Inc: events in each class
ClassEvents
Class II11
Class I6
Share of the events of the firm in Class I
35%
Share of all events on the register in Class I
18%
Events with the status Ongoing
16

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Getinge Usa Sales Inc, by the year that the recall started. The largest year is 2022, with 9 events.

Official channels

Cite this page

Recall Register. Getinge Usa Sales Inc: FDA recalls. https://recallregister.com/firm/getinge-usa-sales-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
NJ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Getinge Usa Sales Inc have?
Class II: 11 events. Class I: 6 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Getinge Usa Sales Inc?
FDA event 96083, which the firm started on 15 Jan 2025. The first product in the record is: Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
How many FDA recalls of Getinge Usa Sales Inc have the status Ongoing?
16 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.