The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2216-2015·Announced 2015-08-05

EXP Pharmaceutical Services Recalls Unregistered Endo Catch Medical Devices

EXP Pharmaceutical Services Corp is recalling two units of Endo Catch 10mm devices because the company failed to register as a medical device establishment or establish 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 identifies the issue as a regulatory compliance failure (lack of registration and quality system) rather than a direct product defect causing injury. Per the rubric, this aligns with moderate severity for administrative or low-risk issues where no specific harm is reported.

Plain-English summary

EXP Pharmaceutical Services Corp is recalling two units of Endo Catch 10mm devices (OEM Catalog number 173050G). These sterile, single-use pouches are manufactured by Auto Suture and repackaged by EXP. The devices were 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 failure to comply with regulatory requirements constitutes the basis for the recall.

Consumers and healthcare facilities that have received these specific devices should stop using them and contact EXP Pharmaceutical Services Corp for instructions on return or disposal. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager), Auto Suture (OEM) Endoscope and Accessories
Manufacturer
EXP Pharmaceutical Services Corp
Category
Medical Device — Endoscopy Accessories
Hazard
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 173050G.

Distribution

Distributed in 6 states:

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 →

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