Exsurco Medical Recalls Amalgatome SD Coaxial Pneumatic Hoses
Exsurco Medical is recalling 70 Amalgatome SD coaxial pneumatic hoses due to improper installation that may cause hose bursts or pressure loss.
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 involves a medical device with a risk of hose burst and pressure loss, which poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Exsurco Medical is recalling 70 units of the Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004. The recall is due to improper installation of the hand piece, which may result in a weakening of the internal hose connection.
This defect can cause a loss of pressure to the device or a hose burst. The affected products were distributed in California, Georgia, Missouri, Ohio, and Texas.
Consumers should check their serial numbers against the list provided in the official recall notice. If a serial number matches, they should stop using the product and contact Exsurco Medical for instructions.
The recalled product
- Product
- Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
- Manufacturer
- Exsurco Medical
- Hazard
- Affected units
- 70
Distribution
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