Ambu Universal Flex2 Breathing Circuits Recalled for Leak Test Failures
King Systems Corp. dba Ambu, Inc. is recalling 871,116 Universal Flex2 Breathing Circuits due to potential leak test failures.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (leak test failure) in a medical device used for breathing, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
King Systems Corp. dba Ambu, Inc. is recalling 871,116 units of Universal Flex2 Breathing Circuits. The recall is due to a potential for leak test failures in the devices.
The affected products were distributed to distributors in 44 U.S. states and internationally to Canada, China, and Chile. The recall covers various item numbers, including D460-6133Z, D390-6121Z, and D495-61Z, among others.
Healthcare facilities and distributors should stop using the affected breathing circuits and contact the manufacturer for further instructions on returns or replacements.
The recalled product
- Product
- UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z…
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Hazard
- Affected units
- 871,116
Distribution
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