Agency classClass IIOur severity:High FDA (Devices)·Z-1741-2017·Announced 2017-04-12

Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

Covidien is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a compromised sterile barrier on a medical device used in surgical or post-injury contexts, which poses a risk of infection. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien Curity Eye Pad, Item Code 91650. The recall is due to a breach of the sterile barrier, which compromises the sterility of the device. These sterile eye pads are intended for use as a bandage over the eye for protection or absorption of secretions, particularly in operating rooms or following injury and surgery to reduce the likelihood of infection.

The recall covers 1,659,500 units. Affected products have lot numbers beginning with 12, 13, 14, 15, or 16 and expiration dates ranging from February 2017 through November 2021. The products were distributed worldwide, including the United States, Canada, Australia, and numerous other international markets.

Consumers and healthcare providers should stop using the affected eye pads immediately. The recall is classified as Class II because the use of the product could, in most cases, cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use…
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Dressings
Hazard: sterility-compromise
infection-risk
Affected units: 1,659,500

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 (5)

Lot Number beginning with: 12
13
14
15
16 Expiration Date: From February 2017 through November 2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Covidien LLC 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 7 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility compromise