Klarity Vacuum Bags — Class II medical device recall Z-2881-2020
Terminated recall by Klarity Medical Products LLC, reported 2020-09-02, distributed nationwide. Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
| Recall number | Z-2881-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Klarity Medical Products LLC, Heath, OH, United States |
| Recall initiated | 2020-07-31 |
| Classified | 2020-08-24 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2020-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 111 units |
| Lot numbers | 70415V, 70502Y, 70621W, 70621Y, 71220V, 71228S, 80411A, 80802W, 81008W, 81008X, R7504-30C, R7504-35BC, R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C |
| Model numbers | R7504-30C, R7504-35BC, R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C |
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.
Reason for recall
Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2881-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.