Lower riskMedical device recall · FDA · Published September 29, 2020
Verathon BladderScan Prime Plus Probe Handle May Crack - Recall
Verathon recalls BladderScan Prime Plus Probe REF 0570-0395 due to handle cracking risk. Affected units have specific serial numbers listed. Stop using if handle cracks.
“Verathon BladderScan Prime Plus Probe Handle May Crack - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64138-verathon-bladderscan-prime-plus-probe-handle-may-crack-recall. Based on FDA recall #Z-0531-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2021%22&limit=1).
The FDA announced on September 29, 2020, that Verathon, Inc. is recalling the BladderScan Prime Plus Probe REF 0570-0395 because the probe handle may crack due to a change in handle material and process. Owners should contact Verathon for further instructions.
How to tell if you have it
Brand: Verathon
Product: BladderScan Prime Plus Probe
REF: 0570-0395
Part Number: 0570-0395
Device Listing Number: D318438
Serial Numbers: P1001848 through P1517920 (specific codes listed in record)
Units affected: 398
The hazard
The probe handle may crack due to a change in handle material and process. The device is intended to be used for measuring urine volume in the bladder noninvasively.
Context
GovInfoNow's records show Verathon, Inc. has had 4 other recalls on record since March 31, 2019. On April 29, 2024, Verathon recalled the GlideScope Core Monitor due to image loss risk with connectable devices. Other recent recalls of similar products include the B. Braun Medical SESK UPMC Double Catheter Tray (January 29, 2026) and the ICU Medical Portex Spinal Tray (December 19, 2025).
How to tell if you have this one
Check if your BladderScan Prime Plus Probe has a serial number starting with P1500000. The specific serial numbers are listed in the recall notice.
Brand
Verathon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Handle Condition
Inspect the probe handle for cracks or signs of damage before use.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 37 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0531-2021 (September 29, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0531-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.