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.
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Ambu
- Product
- Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number…
- Classification
- Class II
- Units
- US Nationwide. Canada.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
US
Ambu 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 →- 2025-05-14
US
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…
FDA · DeviceAmbu Inc.US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ,…Official notice →- 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
- 2024-11-06
US
Olympus Corporation of the Americas recalls Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
US
Westmed, Inc. recalls 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders…
Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.
FDA · DeviceWestmed, Inc.U.S.: AK, CA, CO, DC, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH,…Official notice →US
Integra LifeSciences Corp. recalls Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Out of specification endotoxin levels.
US
Trackx Technology Inc recalls Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate…
The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is…
US
Princeton Biomeditech Corp recalls Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for…
This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user…
US
DRG International, Inc. recalls 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone…
The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to…
FDA · DeviceDRG International, Inc.AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy…Official notice →