--- title: "Ambu Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Ambu Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/ambu-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Ambu Inc. recall records **6** reported ongoing 6 records in this archive. Latest source date Jul 9, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 9, 2025 FDA device enforcement ### [Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 52361...](https://isitonrecall.com/recall/fda-device-z-2181-2025-ambu-spur-ii-labeled-as-the-following-1-spur-ii-adult-resuscitator-adult-catalog-number-523211000-2/) Potential for the manometer port being blocked rendering the manometer non-functional. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Canada. [Official source for Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 52321...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2181-2025%22) Apr 7, 2025 FDA device enforcement ### [Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US](https://isitonrecall.com/recall/fda-device-z-1723-2025-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 inside correctly states 5.6/2.8. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA. [Official source for Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1723-2025%22) Sep 16, 2024 FDA device enforcement ### [Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)](https://isitonrecall.com/recall/fda-device-z-0261-2025-ambu-vivasight-2-dlt-endobronchial-tube-35-fr-catalog-number-412351000-37-fr-catalog-number-41237100/) 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. Class II Reported ongoing Distribution: US Nationwide. Canada. [Official source for Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0261-2025%22) Dec 5, 2023 FDA device enforcement ### [Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2](https://isitonrecall.com/recall/fda-device-z-0714-2024-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 lithium-ion battery and result in a fir... Class II Reported ongoing Distribution: Domestic distribution nationwide. [Official source for Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0714-2024%22) Jul 21, 2023 FDA device enforcement ### [Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 40501...](https://isitonrecall.com/recall/fda-device-z-2628-2023-ambu-aview-2-a-monitor-the-ambu-aview-2-advance-is-intended-to-display-live-imaging-data-from-compat/) 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 Class II Reported ongoing Distribution: Nationwide [Official source for Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from com...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2628-2023%22) Jun 3, 2022 FDA device enforcement ### [Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000](https://isitonrecall.com/recall/fda-device-z-1420-2022-ambu-vivasight-2-dlt-endobronchial-tube-system-used-for-verifying-tube-placement-and-repositioning-c/) 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. Class II Reported ongoing Distribution: Domestic distribution nationwide. Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland... [Official source for Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioni...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1420-2022%22) ## Reasons in these listed records - Potential for the manometer port being blocked rendering the manometer non-functional. - 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 inside correctly states 5.6/2.8. - 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. - 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 lithium-ion battery and result in a fire hazard and battery... These examples come from this result page and are not a ranking of every recall reason. ## Checking Ambu Inc. ### Is there a recall on ambu inc. right now? This archive contains 6 records, including 6 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Ambu Inc.](https://isitonrecall.com/check/?q=Ambu%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)