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.
Read the official notice →- Date
- 2025-10-08
- Country
- United States
- Brand
- Draeger
- Product
- Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan…
- Classification
- Class I
- Units
- Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 → - 2025-08-06
- 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
- 2025-10-08
- US
Zap Surgical Systems recalls ZAP-X Radiosurgery System, Model: 300150
If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software…
FDA · DeviceZap Surgical SystemsWorldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the…Official notice → - US
Bard Peripheral Vascular Inc recalls Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF…
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use.…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution including in the states of NJ, NY, FL,…Official notice → - US
North American Rescue LLC. recalls JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF:…
Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
FDA · DeviceNorth American Rescue LLC.Worldwide - US Nationwide distribution in the states of SC, OK, ID, KY, VA,…Official notice → - US
Medline Industries, LP recalls Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH…
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk…
FDA · DeviceMedline Industries, LPDomestic US distribution nationwide. International distribution pending. No…Official notice → - US
Medline Industries, LP recalls Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Convenience kits labeled as sterile have not gone through the sterilization process.
- US
W L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W,…
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to…
FDA · DeviceW L Gore & Associates, Inc.US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI,…Official notice →