Class II — Sam Medical Products
| Recalling firm | SAM Medical Products |
|---|---|
| Registered facility | SAM MEDICAL PRODUCTS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present. |
| Product | SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 |
| Quantity | 2,950 packages |
| Distribution | U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada |
| Initiated | 2022-01-28 |
| Classified | 2022-03-16 |
| Terminated | 2023-04-06 |
| Recall number | Z-0789-2022 |
| 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 — Sam Medical Products (Z-0789-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89510/
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