Class II — Klarity Medical Products LLC
| Recalling firm | KLARITY MEDICAL PRODUCTS, LLC |
|---|---|
| Registered facility | KLARITY MEDICAL PRODUCTS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times. |
| Product | Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting. |
| Quantity | 111 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK. |
| Initiated | 2020-07-31 |
| Classified | 2020-08-24 |
| Terminated | 2020-10-19 |
| Recall number | Z-2881-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Klarity Medical Products LLC (Z-2881-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86146/
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