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.
Read the official notice →- Date
- 2025-04-09
- Country
- United States
- Brand
- Draeger
- Product
- Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description:…
- Classification
- Class I
- Units
- Domestic: Nationwide Distribution. International - following countries:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 → - 2025-12-17
- US
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.
FDA · DeviceDraeger, Inc.Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and…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 →
Other drugs & medical recalls in the United States
- 2025-04-09
- US
Qiagen Sciences LLC recalls Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
FDA · DeviceQiagen Sciences LLCUS Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.Official notice → - US
Fisher Diagnostics recalls Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
FDA · DeviceFisher DiagnosticsUS Distribution to: PA and OUS Foreign country of: United Arab Emirates.Official notice → - US
Reichert, Inc. recalls Phoroptor VRx Digital Refraction System Model Numbers: 16241
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
FDA · DeviceReichert, Inc.Domestic: Nationwide Distribution. International: Austria, Bolivia, Canada,…Official notice → - US
Terumo Cardiovascular Systems Corporation recalls Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be…
FDA · DeviceTerumo Cardiovascular Systems CorporationUS: IL, TX, NY, MI, FL, NV, and Australia, New ZealandOfficial notice → - US
Stryker Spine recalls Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Potential for the gold unlock button to separate from the inserter.
FDA · DeviceStryker SpineDomestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International:…Official notice → - US
GE Healthcare recalls GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4)…
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login…