EXP Pharmaceutical Services Recalls Laparoscopic Insufflation Needles
EXP Pharmaceutical Services Corp is recalling two units of laparoscopic insufflation needles due to regulatory non-compliance regarding establishment registration and quality systems.
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. The source text describes a regulatory compliance failure (lack of registration/quality system) without reporting any specific physical hazards, injuries, or illnesses, fitting the criteria for a moderate severity voluntary or administrative recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling two units of Medical Device Exchange Insufflation Needles (OEM Catalog number C2201). These sterile, single-use devices are repackaged by EXP and distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas.
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 the fact that its vendors were registered and had their own quality systems. This constitutes a failure to comply with FDA regulatory requirements for medical device manufacturers and repackagers.
No specific health hazards, injuries, or illnesses are reported in the source text. The recall is administrative in nature, addressing compliance with FDA registration and quality system regulations. Consumers and healthcare facilities should stop using the affected devices and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 2
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 C2201.
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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