Class I U.S. Food and Drug Administration

Draeger, Inc. ErgoStar CM 60, Model/ recall: Multiple complaints were reported in which cracks formed in the hose

Recall published 10 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0593-2026
Published
December 17, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Draeger, Inc.
Product type
Medical devices
Units affected
2050 units
Distribution
California, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Wisconsin
Made in
United States
Lot / code info
Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;
UPC codes
04048675420699

Products covered by this recall

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.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04048675420699

Model or item number

On the rating label, the box or the instruction sheet.

  • MP01860

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Draeger, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Draeger, Inc. — 3135 Quarry Rd, Telford, PA, 18969-1042

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Draeger, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04048675420699; model number MP01860. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists California, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Wisconsin.

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