EXP Recalls ETS FLEX 45 Endoscopic Articulating Linear Cutters
EXP Pharmaceutical Services Corp is recalling ETS FLEX 45 endoscopic cutters because the company failed to register as a medical device establishment or maintain its own 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, but the source text indicates a regulatory compliance failure (lack of registration and quality system) rather than a specific product defect or reported injury, fitting the criteria for a moderate severity voluntary or administrative recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling three units of the ETS FLEX 45 Endoscopic Articulating Linear Cutter, 45mm Staple. The product is a sterile, single-use implantable staple device with OEM catalog number ATS45, originally manufactured by Ethicon and repackaged by EXP.
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' registrations and quality systems, which does not meet regulatory requirements for the repackager.
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 these devices and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple.
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 3
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 ATS45.
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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