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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97026

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 16, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Draeger, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

Z-2158-2025
Recall number
Z-2158-2025
Initiated
June 16, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Draeger, Inc.
Quantity
669,838 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. MP05785; UDI: 04048675665762; All Lots.

Distribution pattern

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.

device · product 2 of 4

SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

Z-2159-2025
Recall number
Z-2159-2025
Initiated
June 16, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Draeger, Inc.
Quantity
9,885,139 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Mode No. MP05790; UDI: 04048675558736; All Lots.

Distribution pattern

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.

device · product 3 of 4

HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

Z-2160-2025
Recall number
Z-2160-2025
Initiated
June 16, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Draeger, Inc.
Quantity
1,019,782 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. MP05801; UDI: 04048675665823; All Lots.

Distribution pattern

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.

device · product 4 of 4

SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Z-2161-2025
Recall number
Z-2161-2025
Initiated
June 16, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Draeger, Inc.
Quantity
374,700 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

Field note

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