CLASS I Device recall · Reported 16 May 2018 · FDA Enforcement Report

Fabius Tiro, anesthesia machine recalled by Draeger Medical

Draeger Medical is recalling Fabius Tiro, anesthesia machine, distributed nationwide in the US. The recall was initiated on 1 Mar 2018 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesSerial no: ASKJ-0195 ASKK-0079 ASKF-0226 ASKF-0227 ASKF-0228 ASKF-0229 ASKF-0230 ASKH-0086 ASKH-0071 ASKJ-0177 ASKK-0020 ASKK-0021 ASKH-0053 ASKH-0054 ASKH-0055 ASKH-0056 ASKH-0057 ASKH-0067 ASKH-0068 ASKH-0063 ASKH-0065 ASKH-0064 ASKH-0130 ASKH-0131 ASKJ-0173 ASKH-0031

Quantity recalled26

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-1483-2018
FDA event ID: 79773
Recalling firm: Draeger Medical, Telford, PA
Classification: Class I
Status: Terminated
Recall initiated: 1 Mar 2018
FDA classified: 7 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

1 Mar 2018	Recall initiated by company
7 May 2018	Classified by FDA	+67 days
16 May 2018	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

The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

Product as listed by the FDA

Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).

Where it was distributed

US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.

Nationwide Arizona California Colorado Idaho Illinois Kansas Massachusetts Michigan Mississippi North Carolina New York Ohio Oklahoma Pennsylvania Puerto Rico Rhode Island Tennessee Texas Utah Virginia

Questions about this recall

Is Fabius Tiro, anesthesia machine recalled?

Yes. Draeger Medical recalled Fabius Tiro, anesthesia machine on 1 Mar 2018. The recall is Class I and its status is Terminated. Recall number Z-1483-2018.

Why was it recalled?

The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

Which lots are affected?

Serial no: ASKJ-0195 ASKK-0079 ASKF-0226 ASKF-0227 ASKF-0228 ASKF-0229 ASKF-0230 ASKH-0086 ASKH-0071 ASKJ-0177 ASKK-0020 ASKK-0021 ASKH-0053 ASKH-0054 ASKH-0055 ASKH-0056 ASKH-0057 ASKH-0067 ASKH-0068 ASKH-0063 ASKH-0065 ASKH-0064 ASKH-0130 ASKH-0131 ASKJ-0173 ASKH-0031

Where was it sold?

US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.

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 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.

More recalls from Draeger Medical

All 78

Reported	Class	Recall	Company	Reason	Where
25 Dec 2024Device	CLASS I	Atlan A300 recalled by Draeger Medical	Draeger Medical	Device Malfunction	PA
25 Dec 2024Device	CLASS I	Atlan A300XL recalled by Draeger Medical	Draeger Medical	Device Malfunction	PA
20 Nov 2024Device	CLASS I	Atlan A350 recalled by Draeger Medical	Draeger Medical	Device Malfunction	Nationwide
20 Nov 2024Device	CLASS I	Atlan A350XL recalled by Draeger Medical	Draeger Medical	Device Malfunction	Nationwide
24 Apr 2024Device	CLASS I	Dr¿ger Perseus A500 Anesthesia Workstation recalled by Draeger Medical	Draeger Medical	Device Malfunction	Nationwide

Other CPAP & Ventilators recalls

All 552

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo-n recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical AG	Device Malfunction	Nationwide