CLASS I ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report

SafeStar 60A Plus Filter recalled by Draeger

Draeger is recalling SafeStar 60A Plus Filter, distributed nationwide in the US. The recall was initiated on 16 Jun 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel No. MP05795; UDI: 04048675665786; All Lots.

Quantity recalled374,700 units

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-2161-2025
FDA event ID: 97026
Recalling firm: Draeger, Telford, PA
Classification: Class I
Status: Ongoing
Recall initiated: 16 Jun 2025
FDA classified: 31 Jul 2025
Reported: 6 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Jun 2025	Recall initiated by company
31 Jul 2025	Classified by FDA	+45 days
6 Aug 2025	Published in enforcement report	+6 days

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

Reason for recall

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Product as listed by the FDA

SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Where it was distributed

Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.

Nationwide Alaska Arizona California Colorado Connecticut Florida Idaho Illinois Indiana Louisiana Massachusetts Maine Michigan Minnesota Missouri North Carolina Nebraska New Mexico Nevada New York

Questions about this recall

Why was it recalled?

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Which lots are affected?

Model No. MP05795; UDI: 04048675665786; All Lots.

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.

Other products in this recall event

3 other products · FDA event 97026

This product is part of a recall event; the main page for the event is SafeStar 90 Plus Filter recalled by Draeger.

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025	CLASS I	SafeStar 90 Plus Filter recalled by Draeger	Draeger	Other	Nationwide
6 Aug 2025	CLASS I	SafeStar 55 Plus Filter recalled by Draeger	Draeger	Other	Nationwide
6 Aug 2025	CLASS I	HME TwinStar HEPA Plus Filter recalled by Draeger	Draeger	Other	Nationwide

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