FSC Laboratories Recalls Flexichamber Holding Chambers Due to Seal Defects
FSC Laboratories is recalling 1,435 Flexichamber Anti-Static Valved Collapsible Holding Chambers because the seal around the mouthpiece was torn or loose.
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, and the defect (torn/loose seal) is a quality issue that may affect medication delivery but does not involve high-risk pathogens or reported serious injuries, fitting the Moderate criteria for minor defects or low-risk issues.
Plain-English summary
FSC Laboratories, Inc. is recalling 1,435 units of the Flexichamber Anti-Static Valved Collapsible Holding Chamber. This device is used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers (pMDIs). The recall was initiated because the product had a torn or loose seal around the mouthpiece.
The affected units were distributed nationwide in the United States. The specific lots involved are Lot 5295 (trade) with NDC 13551-901-01, and Lots 5313 (demonstration units) and 5325 with NDC 13551-902-01.
Consumers who possess these specific lots should stop using the device and contact FSC Laboratories, Inc. for further instructions or a replacement.
The recalled product
- Product
- Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
- Manufacturer
- FSC Laboratories, Inc
- Affected units
- 1,435
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 (2)
- Lot 5295 (trade) NDC 13551-901-01
- Lot 5313 (demonstration units) and 5325 NDC 13551-902-01
Distribution
Distributed nationwide across the United States.
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