Recall Register

Food, drugs, devices › Firms

CooperVision, Inc.

FDA recalling firm · 12 enforcement events · 33 product records · 2013–2025 · NY

CooperVision, Inc. has 12 FDA enforcement events on this register (33 product records) between 2013 and 2025: 12 device; the busiest year was 2025 with 3.

0% of its events are Class I; the most common class is Class II (10). 7 events are listed as ongoing; the recalling firm's address is in NY.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
22 Aug 2025MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.DeviceClass II3Ongoing
16 Jun 2025Biofinity XR Toric Contact LensDeviceClass II2Ongoing
27 Feb 2025Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUBLAN PREMIUM OXYGEN 1 DAY TORIC, EV…DeviceClass II1Ongoing
29 Aug 2024BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.DeviceClass II2Ongoing
14 Feb 2023Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90DeviceClass II1Ongoing
26 Jan 2023Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)DeviceClass II2Ongoing
27 Dec 2022MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.DeviceClass II1Ongoing
19 May 2021CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blockerDeviceClass II12Terminated
13 Jan 2020Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)DeviceClass II2Terminated
21 Feb 2018clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in…DeviceClass III4Terminated
1 Sep 2017Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic…DeviceClass III1Terminated
20 Nov 2013Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lensesDeviceClass II2Terminated

By type and class

Device12
Class II10
Class III2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for CooperVision, Inc. by year initiated.

Questions and answers

How many FDA recalls has CooperVision, Inc. had?

12 enforcement events (33 product records) on this register, 2013–2025: 12 device.

Are any CooperVision, Inc. recalls ongoing?

7 events are listed as ongoing in the current openFDA export.

What class are CooperVision, Inc. recalls?

10 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.