CLASS II Device recall · Reported 12 Apr 2017 · FDA Enforcement Report
Curity Eye Pad recalled by Covidien
Covidien is recalling Curity Eye Pad, distributed nationwide in the US. The recall was initiated on 3 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1741-2017
- FDA event ID
- 76606
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Mar 2017
- FDA classified
- 6 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Mar 2017 | Recall initiated by company | |
| 6 Apr 2017 | Classified by FDA | +34 days |
| 12 Apr 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product sterility is compromised due to breach of sterile barrier
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Product sterility is compromised due to breach of sterile barrier
Which lots are affected?
Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 76606This product is part of a recall event; the main page for the event is Curity Wet Dressing 8 x 4 x, Sterile recalled by Covidien.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Curity Wet Dressing 8 x 4 x, Sterile recalled by Covidien | Covidien | Sterility | Nationwide | |
| CLASS II | Curity Eye Pad recalled by Covidien | Covidien | Sterility | Nationwide | |
| CLASS II | Curity Saline Dressing 8' x 4 x10., Sterile recalled by Covidien | Covidien | Sterility | Nationwide | |
| CLASS II | Curity Eye Pad Oval, 1-5/8 x 2-5/8 x, Sterile recalled by Covidien | Covidien | Sterility | Nationwide | |
| CLASS II | Kerlix Super Sponge Saline Dressing, Sterile recalled by Covidien | Covidien | Sterility | Nationwide | |
| CLASS II | Curity Sodium Chloride Dressing , 6 x 6-3/4 x, Sterile recalled | Covidien | Sterility | Nationwide |
More recalls from Covidien
All 493| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EndoFLIP System that includes recalled by Covidien | Covidien | Other | Nationwide |
| Device | CLASS II | Dermalon 88861757-31 Dermalon* 4-0 Blu C13 recalled by Covidien | Covidien | Sterility | Nationwide |
| Device | CLASS II | Surgipro SP-623 Surgipro* 2-0 BLU SC2 X36 SP recalled by Covidien | Covidien | Sterility | Nationwide |
| Device | CLASS II | V-Loc 90 Absorbable Wound Closure Device Vloc 90 0 VL recalled | Covidien | Sterility | Nationwide |
| Device | CLASS II | Surgipro II S8698GX Surgipro II BL 5/0 18 P-13 S8698GX recalled | Covidien | Sterility | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |