EXP Pharmaceutical Services Recalls Unregistered GIA Auto Suture Loading Units
EXP Pharmaceutical Services Corp is recalling GIA Auto Suture Loading Units because the company failed to register as a medical device establishment or establish 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 cites regulatory non-compliance (failure to register and establish quality systems) rather than a specific physical defect or reported injury, fitting the criteria for a moderate severity voluntary or regulatory recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling one unit of the GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm. The product is a sterile, single-use implantable staple pouch with OEM Catalog number GIA8048L, originally manufactured by Covidien.
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 units 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 product and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien (OEM) Implantable Staple
- 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 GIA8048L.
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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