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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97923

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

Open FDA event record

Event summary

Timeline bucket
November 10, 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

ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Z-0590-2026
Recall number
Z-0590-2026
Initiated
November 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Draeger, Inc.
Quantity
14420 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Code information

Model/Catalog Number: MP01840; UDI Number:04048675420736; Lot numbers: All lot numbers

Distribution pattern

Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.

device · product 2 of 4

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Z-0591-2026
Recall number
Z-0591-2026
Initiated
November 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Draeger, Inc.
Quantity
191470 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Code information

Model/Catalog Number: MP01845; UDI Number: 04048675420729; Lot numbers: All lot numbers;

Distribution pattern

Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.

device · product 3 of 4

ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Z-0592-2026
Recall number
Z-0592-2026
Initiated
November 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Draeger, Inc.
Quantity
118850 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Code information

Model/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers;

Distribution pattern

Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.

device · product 4 of 4

ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Z-0593-2026
Recall number
Z-0593-2026
Initiated
November 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Draeger, Inc.
Quantity
2050 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Code information

Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;

Distribution pattern

Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.