Food, drugs, devices › Verathon, Inc.
Device recall: BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bl
Verathon, Inc. (Bothell, WA) initiated this device recall on 29 Sep 2020; FDA lists 1 product record under event 86528, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 29 Jun 2022. Initiation: voluntary: firm initiated. Verathon, Inc. has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Verathon, Inc., Bothell, WA.
Reason for recall
"Due to a change in handle material and process, probe handle may crack."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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. | 398 units | Class II | Terminated | 9 Dec 2020 |
Context
Other enforcement events for Verathon, Inc.
All 12 events for Verathon, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to a change in handle material and process, probe handle may crack."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Jun 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.