BladderScan Prime Plus Probe REF 0570-0395 — Class II medical device recall Z-0531-2021
Terminated recall by Verathon, Inc., reported 2020-12-09, distributed nationwide. Due to a change in handle material and process, probe handle may crack.
| Recall number | Z-0531-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Verathon, Inc., Bothell, WA, United States |
| Recall initiated | 2020-09-29 |
| Classified | 2020-12-03 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2022-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, DE, FR, GB, KW, LU, NZ, PT, SE, SG, TW |
| Quantity | 398 units |
| Reason classes | packaging |
| Serial numbers | P1001848, P1500333, P1500436, P1500486, P1500517, P1500519, P1500528, P1500604, P1500642, P1500657, P1501000, P1501088, P1501102, P1501115, P1501122, P1501247, P1501255, P1501259, P1501326, P1501330, P1501394, P1501399, P1501607, P1501625, P1501739 and 248 more |
| Model numbers | 0570-0395 |
Product
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Reason for recall
Due to a change in handle material and process, probe handle may crack.
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-0531-2021. 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.