The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2227-2015·Announced 2015-08-05

EXP Pharmaceutical Services Recalls Unregistered Implantable Skin Staple Systems

EXP Pharmaceutical Services Corp is recalling three units of implantable skin staple systems 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. The source text identifies a regulatory compliance failure (lack of registration and quality system) rather than a specific product defect or reported injury. Per the rubric, this aligns with a moderate severity score for a Class II recall without reported adverse events.

Plain-English summary

EXP Pharmaceutical Services Corp is recalling three units of the Tacker Skin 5mm Implantable Staple System. The recalled product is identified by OEM Catalog number 6206 and is packaged in a sterile, single-use Tyvek/Mylar pouch. 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 with the FDA, 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. This failure to comply with regulatory requirements constitutes the basis for the recall.

Consumers and healthcare facilities that have received these specific units should stop using them and contact EXP Pharmaceutical Services Corp for further instructions. The recall is limited to the three units described in the source text.

The recalled product

Product
Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
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 6206.

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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