CLASS I ONGOING Device recall · Reported 19 Jan 2022 · FDA Enforcement Report

Vaporizer Sevoflurane Maquet Filling recalled by Getinge Usa Sales

Getinge Usa Sales is recalling Vaporizer Sevoflurane Maquet Filling, distributed nationwide in the US. The recall was initiated on 9 Dec 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI: 07325710008430 Serial Nos. 15580 15890 15924 16284 16637 16837 16970 15582 15891 15925 16285 16638 16840 16971 15721 15894 16268 16345 16639 16842 15722 15914 16269 16352 16640 16843 15725 15917 16270 16354 16690 16844 15726 15919 16271 16632 16828 16961 15728 15920 16272 16633 16832 16964 15729 15921 16273 16634 16833 16965 15731 15922 16276 16635 16834 16966 15732 15923 16283 16636 16836 16968

Quantity recalled50 US; 898 OUS

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-0468-2022
FDA event ID: 89125
Recalling firm: Getinge Usa Sales, Wayne, NJ
Classification: Class I
Status: Ongoing
Recall initiated: 9 Dec 2021
FDA classified: 10 Jan 2022
Reported: 19 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

9 Dec 2021	Recall initiated by company
10 Jan 2022	Classified by FDA	+32 days
19 Jan 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Vaporizer 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 Flow-i Anesthesia System C40 6888540 07325710010631 Flow-i C20 Anesthesia System 6677200 07325710001349 Flow-i C30 Anesthesia System 6677300 07325710001349 Flow-i C40 Anesthesia System 6677400 07325710001318

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of VA and MO. The countries of Austria, Bahrain, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Estonia, Iraq, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Morocco, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Nationwide Missouri Virginia

Questions about this recall

Why was it recalled?

A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.

Which lots are affected?

UDI: 07325710008430 Serial Nos. 15580 15890 15924 16284 16637 16837 16970 15582 15891 15925 16285 16638 16840 16971 15721 15894 16268 16345 16639 16842 15722 15914 16269 16352 16640 16843 15725 15917 16270 16354 16690 16844 15726 15919 16271 16632 16828 16961 15728 15920 16272 16633 16832 16964 15729 15921 16273 16634 16833 16965 15731 15922 16276 16635 16834 16966 15732 15923 16283 16636 16836 16968

Where was it sold?

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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.

More recalls from Getinge Usa Sales

All 47

Reported	Class	Recall	Company	Reason	Where
19 Feb 2025Device	CLASS I	Vaporizer Sevoflurane, Quik-Fil recalled by Getinge Usa Sales	Getinge Usa Sales	Other	CT, KY
20 Nov 2024Device	CLASS II	Meera CL mobile operating table - Designed recalled by Getinge Usa Sales	Getinge Usa Sales	Other	Nationwide
20 Nov 2024Device	CLASS II	Meera CL mobile operating table - Designed recalled by Getinge Usa Sales	Getinge Usa Sales	Other	Nationwide
20 Nov 2024Device	CLASS II	Meera CL mobile operating table - Designed recalled by Getinge Usa Sales	Getinge Usa Sales	Other	Nationwide
20 Nov 2024Device	CLASS II	Meera CL mobile operating table - Designed recalled by Getinge Usa Sales	Getinge Usa Sales	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide