EXP Pharmaceutical Services Recalls Unregistered Suction Coagulator Devices
EXP Pharmaceutical Services Corp is recalling sterile suction coagulator devices because the company failed to register as a medical device establishment or establish a quality system.
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 indicates a regulatory compliance failure (lack of registration/quality system) rather than a specific product defect or reported injury, fitting the criteria for a moderate severity voluntary/precautionary recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling sterile, single-use suction coagulator devices (OEM Catalog number E2505-10FR) manufactured by Valleylab. The recall involves one unit of the device, which is packaged in a Tyvek/Mylar pouch.
The recall was initiated because EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system. Instead, the company relied on its vendors being registered and having their own quality systems.
The affected devices were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare facilities should stop using the recalled devices and contact EXP Pharmaceutical Services Corp for instructions on return or replacement.
The recalled product
- Product
- Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR; EXP (repackager), Valleylab (OEM) Electrosurgical, cutting & coagulation & accessories
- Manufacturer
- EXP Pharmaceutical Services Corp
- 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 E2505-10FR.
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.
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