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.

Read the official notice →
Date
2026-10-07
Country
United States
Brand
Draeger
Product
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Classification
Class I
Units
US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2026-06-10
  2. 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 →
  3. 2025-12-31
  4. 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 →
  5. 2025-12-17
  6. 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 →
  7. 2025-10-08
  8. 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 →
  9. 2025-08-06
  10. US
    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.

    FDA · DeviceDraeger, Inc.Worldwide - US Nationwide distribution including in the states of AK, AZ, CA,…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. 2026-10-07
  2. US
    Drugs & medicalClass II

    Bard Peripheral Vascular Inc recalls EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER)…

    Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to…

    FDA · DeviceBard Peripheral Vascular IncUS Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC,…Official notice →
  3. US
    Drugs & medicalClass II

    Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/…

    hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

    FDA · DeviceAlere San Diego, Inc.Worldwide - US Nationwide distribution including in the states of IL, PA, FL,…Official notice →
  4. US
    Drugs & medicalClass III

    HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes:…

    Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

    FDA · DeviceHeartSine Technologies LtdU.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO,…Official notice →
  5. US
    Drugs & medicalClass I

    Medline Industries, LP recalls Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE

    Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire.…

    FDA · DeviceMedline Industries, LPDistribution US Nationwide including territories of Puerto Rico and Guam and…Official notice →
  6. US
    Drugs & medicalClass II

    Philips North America Llc recalls Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

    The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional…

    FDA · DevicePhilips North America LlcU.S. and U.S. Territories.Official notice →
  7. US
    Drugs & medicalClass II

    Illumina, Inc. recalls NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130

    Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability.

    FDA · DeviceIllumina, Inc.Worldwide - US Nationwide distribution in the states of TX, KS, NC, CA, UT,…Official notice →
See all drugs & medical recalls →