Draeger, Inc. recalls ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the…
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Read the official notice →- Date
- 2025-12-17
- Country
- United States
- Brand
- Draeger
- Product
- ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the…
- Classification
- Class I
- Units
- Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Draeger recalls
- 2026-10-07
USDraeger, Inc. recalls VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Potential cracks in the hose, which could lead to leakage or the hose falling off.
FDA · DeviceDraeger, Inc.US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO,…Official notice →- 2026-06-10
- US
Draeger, Inc. recalls Atlan A350XL. Model Number: 8621600. anesthesia workstation
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger, Inc.US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND.…Official notice → - 2025-12-31
- US
Draeger, Inc. recalls Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
FDA · DeviceDraeger, Inc.Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS,…Official notice → - 2025-10-08
- US
Draeger, Inc. recalls Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan…
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger, Inc.Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the…Official notice → - 2025-08-06
- US
Draeger, Inc. recalls SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
FDA · DeviceDraeger, Inc.Worldwide - US Nationwide distribution including in the states of AK, AZ, CA,…Official notice → - 2025-04-09
- US
Draeger, Inc. recalls Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description:…
The potential for cracks forming in the breathing circuit hose.
FDA · DeviceDraeger, Inc.Domestic: Nationwide Distribution. International - following countries:…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-17
- US
Medline Industries, LP recalls MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that…
- US
GE Medical Systems, LLC recalls Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
- US
Philips North America recalls Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance…
- US
Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL…
Defective container - seal not adhering to bottles
- US
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard,…
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- US
Winder Laboratories, LLC recalls Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories,…
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.