EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging Operations
EXP Pharmaceutical Services Corp is recalling 12x40 Airway Stent Systems due to failure to register as a medical device establishment and lack of a quality system.
What this means for you
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. The source text identifies a regulatory compliance failure (lack of registration and quality system) rather than a specific product defect or reported injury, aligning with the 'Moderate' severity criteria for administrative or low-risk issues.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling 12x40 Airway Stent Systems (OEM Catalog number 90129-212). The product is a sterile, single-use, expandable tracheal prosthesis repackaged by EXP from the original manufacturer, Aero.
The recall was initiated because EXP did not register as a medical device establishment, did not list the devices being recalled, and did not establish its own quality system. Instead, the company relied on its vendors being registered and having their own quality systems. This regulatory non-compliance constitutes the basis for the recall action.
The affected units were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare providers should stop using these devices and contact EXP Pharmaceutical Services Corp for further instructions or a return.
The recalled product
- Product
- Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
- Manufacturer
- EXP Pharmaceutical Services Corp
- Category
- Medical Device — Airway Stent
- Affected units
- 1
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 (1)
- OEM Catalog number 90129-212.
Distribution
Part of a larger recall action
This product is one of 42 recalled by EXP Pharmaceutical Services Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
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