Ambu Inc. recalls Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product…
Read the official notice →- Date
- 2025-05-14
- Country
- United States
- Brand
- Ambu
- Product
- Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Ambu recalls
- 2025-08-20
USAmbu Inc. recalls Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator…
Potential for the manometer port being blocked rendering the manometer non-functional.
FDA · DeviceAmbu Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice →- 2024-11-06
- US
Ambu Inc. recalls Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number…
Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.
- 2024-01-17
- US
Ambu Inc. recalls Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the…
- 2023-10-04
- US
Ambu Inc. recalls Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices,…
Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames
- 2022-07-27
- US
Ambu Inc. recalls Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000,…
Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.
FDA · DeviceAmbu Inc.Domestic distribution nationwide. Foreign distribution to Austria, Belgium,…Official notice →
Other drugs & medical recalls in the United States
- 2025-05-14
- US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May…
FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide - US Nationwide distribution including in the states of AZ, VA, FL,…Official notice → - US
Inari Medical - Oak Canyon recalls Artix MT Thrombectomy Device, REF: 32-102
Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery,…
FDA · DeviceInari Medical - Oak CanyonUS Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA,…Official notice → - US
Integra LifeSciences Corp. (NeuroSciences) recalls INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)US Nationwide distribution in the states of TX, MT, AL & OK.Official notice → - US
Philips North America Llc recalls Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm…
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of AE, AL, AO, AR,…Official notice → - US
Getinge Disinfection Ab recalls Washer Disinfector Aquadis 56; Model Number: 56M
The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the…
FDA · DeviceGetinge Disinfection AbWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.