EXP Pharmaceutical Services Recalls Unregistered Sterile Laparoscope Pouches
EXP Pharmaceutical Services Corp is recalling seven sterile laparoscope pouches 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 does not report any illnesses, injuries, or specific safety hazards, indicating a regulatory compliance issue rather than a direct health risk.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling seven units of sterile, single-use laparoscope pouches (KII FIOS FIRST ENTRY 5X100MM, OEM Catalog number CFF03). The product is manufactured by Applied Medical and repackaged by EXP. These devices are intended for use in general and plastic surgery.
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. The agency classification for this recall is Class II.
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 specific pouches and contact the recalling firm for further instructions.
The recalled product
- Product
- Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 7
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 CFF03.
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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