Home › I-Med Pharma Inc › I-RELIEF Hot and Cold Therapy Eye Mask
I-RELIEF Hot and Cold Therapy Eye Mask
I-Med Pharma Inc · Model 0890 · UDI-DI 00622554008907
10
510(k) clearances
391
Adverse events (1 deaths)
12
Recalls
474
Facilities
Description
Hot & Cold Therapy Eye Mask with ThermaBeadsTM for the relief of symptoms associated with Blepharitis, Dry Eye Disease, Meibomian Gland Disease (MGD), Styes and Chalazia as well as headaches, sinus pressure, tension, swelling and puffiness.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-25 | DJO, LLC | The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2021-12-15 | MEDLINE INDUSTRIES, LP - Northfield | The product contains natural rubber latex but the label states that it does not. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.