FDA Recalls Ambu Aura40 Reusable Laryngeal Masks Due to Labeling Error
Besmed Health Business Corporation is recalling Ambu Aura40 Standard reusable laryngeal masks because they are packaged in pouches marked as single-use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to a labeling error regarding the reusability of the device, which fits the criteria for moderate severity involving minor labeling issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Ambu Aura40 Standard, Reusable Laryngeal Masks (Catalog Number: 340300000) manufactured by Besmed Health Business Corporation. The recall involves 267 units distributed nationwide in the United States and in Canada. The affected products are identified by Lot Numbers MO0612G40021 and MO0605G40014.
The reason for the recall is a labeling discrepancy: the reusable laryngeal masks are packaged in pouches marked "AuraStraight Silicone, Single Use Laryngeal Mask Sterile." This packaging incorrectly identifies the product as single-use rather than reusable.
Healthcare providers and consumers should stop using these specific units and contact Besmed Health Business Corporation for further instructions or a replacement.
The recalled product
- Product
- Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
- Manufacturer
- Besmed Health Business Corporation
- Hazard
- Affected units
- 267
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: MO0612G40021 and MO0605G40014
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighAmbu Aura Gain Laryngeal Masks Recalled for Sterility Assurance Failure
FDA (Devices) · 2016-03-30
- ModerateResmed Recalls 42 Quattro Air FFM Masks Due to Sizing and Venting Errors
FDA (Devices) · 2016-08-24
- ModerateUltrasound gel recalled for mislabeling with inappropriate use instructions
FDA (Devices) · 2023-09-20
- ModerateFDA recalls MAC laryngoscope sets due to packaging error
FDA (Devices) · 2022-07-06
- HighAMD Medicom Level 2 Masks Recalled Due to Packaging Error
FDA (Devices) · 2019-11-27
- ModerateMedical Action Industries Recalls Foam Protective Pouches Due to Labeling Error
FDA (Devices) · 2024-09-18