Drugs & medicalClass I

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.

Read the official notice →
Date
2025-08-06
Country
United States
Brand
Draeger
Product
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Classification
Class I
Units
Worldwide - US Nationwide distribution including in the states of AK, AZ, CA,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2026-10-07
  2. US
    Drugs & medicalClass I

    Draeger, 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 →
  3. 2026-06-10
  4. US
    Drugs & medicalClass I

    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 →
  5. 2025-12-31
  6. US
    Drugs & medicalClass I

    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 →
  7. 2025-12-17
  8. US
    Drugs & medicalClass I

    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 →
  9. 2025-10-08
  10. US
    Drugs & medicalClass I

    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 →
  11. 2025-04-09
  12. US
    Drugs & medicalClass I

    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 →
All 7 Draeger recalls →

Other drugs & medical recalls in the United States

  1. 2025-08-06
  2. US
    Drugs & medicalClass II

    Implant Direct Sybron Manufacturing LLC recalls The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop…

    The Drill stop kit contains incorrect components.

    FDA · DeviceImplant Direct Sybron Manufacturing LLCWorldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ,…Official notice →
  3. US
    Drugs & medicalClass I

    Hamilton Medical AG recalls Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and…

    Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete…

    FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC,…Official notice →
  4. US
    Drugs & medicalClass I

    Abiomed, Inc. recalls Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU;…

    A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

    FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei…Official notice →
  5. US
    Drugs & medicalClass II

    Apic Yamada America recalls Molding Equipment. WCM series. Model WCM-330GL-i

    Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.

    FDA · DeviceApic Yamada AmericaUSOfficial notice →
  6. US
    Drugs & medicalClass II

    Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC#…

    Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds

    FDA · DrugHikma Pharmaceuticals USA Inc.Distributed Nationwide in the USAOfficial notice →
  7. US
    Drugs & medicalClass II

    Nostrum Laboratories, Inc. recalls Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx…

    CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity…

    FDA · DrugNostrum Laboratories, Inc.nationwide within the United StatesOfficial notice →
See all drugs & medical recalls →