Apollo Endosurgery Recalls LAP-BAND AP Systems Distributed Past Expiration
Apollo Endosurgery is recalling 10 LAP-BAND AP Systems distributed past their expiration date in seven states.
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 explicitly states no illnesses or injuries were reported and the hazard is limited to distribution past expiration date, fitting the criteria for a moderate severity score.
Plain-English summary
Apollo Endosurgery Inc is recalling 10 units of the LAP-BAND AP System AP Large with Access Port and LAP-BAND AP System Access Port I. The recall is due to the product being distributed past its expiration date. The LAP-BAND System is indicated for weight reduction for patients with obesity, specifically those with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions.
The affected products were distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon. The specific units involved are the Lap-Band System AP Standard with Catalog Number B-2240 and the following serial numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, and 17704653.
Patients who have had this device implanted should contact their healthcare provider for instructions on what to do next. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at…
- Manufacturer
- Apollo Endosurgery Inc
- Hazard
- Affected units
- 10
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 (11)
- Lap-Band System AP Standard Catalog Number B-2240
- Serial Numbers: 17760203
- 17704664
- 17704665
- 17760205
- 17760179
- 17704672
- 17704667
- 17704659
- 17760194
- 17704653
Distribution
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