Apollo Lap-Band System Recalled Due to Missing Component
Apollo Endosurgery Inc. is recalling 54 units of the Apollo Lap-Band AP System Small with RapidPort EZ because a component was missing from the package.
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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a missing component, which is a quality control issue rather than a direct safety hazard like a defect causing injury. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary recalls where no harm is reported.
Plain-English summary
Apollo Endosurgery Inc. is recalling 54 units of the Apollo Lap-Band AP System Small with RapidPort EZ. The recall was initiated because a component of the Lap-Band system was missing from the package. The product is a medical device used for weight loss that consists of a silicone band, access port, and tubing.
The affected units were distributed worldwide, including in the United States (FL, IL, LA, MI, MO, NC, NY, TN, TX, VA, and WV) and in France, Italy, Spain, and the United Kingdom. The specific lot and serial numbers are listed in the structured product information.
Patients who have had this device implanted should contact their healthcare provider for guidance. The manufacturer is responsible for the recall and will provide further instructions to affected parties.
The recalled product
- Product
- Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the…
- Manufacturer
- Apollo Endosurgery Inc
- Hazard
- Affected units
- 54
Distribution
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