Class II — Verathon, Inc.
| Recalling firm | Verathon Inc. |
|---|---|
| Registered facility | Verathon Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to a change in handle material and process, probe handle may crack. |
| Product | BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively. |
| Quantity | 398 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV and WY. The countries of Austrailia, Belgium, Canada, France, Germany, Kuwait, Luxembourg, New Zealand, Portugal, Singapore, Sweden, Switzerland, Taiwan, and United King… |
| Initiated | 2020-09-29 |
| Classified | 2020-12-03 |
| Terminated | 2022-06-29 |
| Recall number | Z-0531-2021 |
| 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 — Verathon, Inc. (Z-0531-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86528/
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