EXP Recalls Unregistered Implantable Clips Due to Regulatory Non-Compliance
EXP Pharmaceutical Services Corp is recalling 17 units of implantable clips because the company failed to register as a medical device establishment or maintain 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 cites regulatory non-compliance (lack of registration and quality system) rather than a specific product defect or reported injury, aligning with the criteria for moderate severity.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling 17 units of implantable clips (OEM Catalog number 3299) distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. The product is identified as a Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only, with EXP acting as the repackager and Covidien as the OEM.
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 the fact that its vendors were registered and had their own quality systems.
Consumers and healthcare providers who have these specific units should stop using them and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 17
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 3299.
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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