The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2224-2015·Announced 2015-08-05

EXP Pharmaceutical Services Recalls Unregistered Auto Suture Endo Universal Devices

EXP Pharmaceutical Services Corp is recalling three Auto Suture Endo Universal devices because the company failed to register as a medical device establishment or establish its own 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 indicates the hazard is administrative (failure to register and establish quality systems) rather than a direct physical 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 Auto Suture Endo Universal 65 4mm devices. These sterile, single-use devices are packaged in Tyvek/Mylar pouches and are intended for use in laparoscopic general and plastic surgery. 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 Pharmaceutical Services Corp 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 the fact that its vendors were registered and had their own quality systems. The agency has classified this recall as Class II.

Consumers and healthcare facilities that have received these specific devices should stop using them and contact EXP Pharmaceutical Services Corp for further instructions. The recall involves a limited quantity of three units.

The recalled product

Product
Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery
Manufacturer
EXP Pharmaceutical Services Corp
Category
Medical Device — Surgical Instruments
Hazard
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 173054.

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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