Z-1741-2017Class II

Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of...

Name: Z-1741-2017 Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of...
Creator: Covidien LLC
Published: 2017-03-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-03-03 / Terminated / root cause: packaging

FDA source

Covidien LLC began a recall of 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... on 2017-03-03. FDA classified it as Class II and gives the reason as "Product sterility is compromised due to breach of sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1741-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Posted: 2017-03-27
Terminated: 2019-10-07
Recalling firm: Medtronic, Inc.
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 in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection
Product code: HMP Pad, Eye
Reason for recall: Product sterility is compromised due to breach of sterile barrier
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Contact Medtronic representative or Customer Service at (800) 882-5878 For questions regarding this recall call 203-492-5000.
Quantity in commerce: 1659500
Distribution: Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, and United Kingdom.
Product codes and lots: Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1741-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1739-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06
Z-1740-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06
Z-1741-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06
Z-1742-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06
Z-1743-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06
Z-1744-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06
Z-1745-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06

Product code HMP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)