Class II — Exact Medical Manufacturing, Inc.
| Recalling firm | Exact Medical Manufacturing, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | No 510k for the product to be used in a natural or surgical opening to the body |
| Product | Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360 |
| Quantity | 500 units |
| Distribution | US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico |
| Initiated | 2021-04-29 |
| Classified | 2021-06-21 |
| Terminated | 2022-05-26 |
| Recall number | Z-1916-2021 |
| 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 — Exact Medical Manufacturing, Inc. (Z-1916-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87958/
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