FDA Device recall Z-0531-2021
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively
- FDA Device
- Class II
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively by Verathon, citing due to a change in handle material and process, probe handle may crack.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0531-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-29 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Verathon |
| Distribution | US |
Product
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Reason
Due to a change in handle material and process, probe handle may crack.
Identifiers
| code_info | Part Number: 0570-0395 Device Listing Number: D318438 UDI Code: 0 0879123 00649 3 Serial Numbers: P1001848 P150033…Part Number: 0570-0395 Device Listing Number: D318438 UDI Code: 0 0879123 00649 3 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 P1501765 P1501779 P1501788 P1501845 P1501911 P1501979 P1502058 P1503069 P1503070 P1503071 P1503072 P1503073 P1503074 P1503075 P1503076 P1503077 P1503078 P1503079 P1503080 P1503081 P1503082 P1503083 P1503084 P1503085 P1503086 P1503087 P1503088 P1503089 P1503093 P1503096 P1503098 P1503099 P1503100 P1503102 P1503104 P1503106 P1503109 P1503110 P1503111 P1503112 P1503113 P1503114 P1503117 P1503118 P1504415 P1504427 P1504463 P1504564 P1504664 P1504754 P1504906 P1505005 P1505019 P1505119 P1505133 P1505181 P1505208 P1505479 P1505481 P1505491 P1505496 P1505506 P1505531 P1505676 P1505695 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.