Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported April 2, 2025
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscos…
Calyxo, Inc. recalled CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic… - a critical-severity action.
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic… was recalled by Calyxo, Inc. in April 2, 2025. Reason: Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labelin…. Check the official notice for the remedy. Verify recall #Z-1396-2025 with the FDA Devices before acting.
The recall
Calyxo, Inc. issued this critical-severity FDA Devices recall-Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labelin….
- Critical
- severity level
- 11K units
- affected scope
- Class I
- classification
- April 2, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1396-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1396-2025) was formally reported on April 2, 2025, with the manufacturer initiating the action on February 19, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Calyxo, Inc. is listed as the recalling firm, operating out of Pleasanton, CA. Federal records list the affected scope as 11,246.
The documented reason for this recall is: Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue… Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
11,246
Related Recalls
6
3 from same agency
Product description
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Reason for recall
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1396-2025 |
| Date reported | April 2, 2025 |
| Date initiated | February 19, 2025 |
| Recalling firm | Calyxo, Inc. |
| Firm location | Pleasanton, CA |
| Affected scope | 11,246 |
| Distribution | US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1396-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.. Recalled by Calyxo, Inc.. Units affected: 11,246.
Why was this product recalled? ▼
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2025. Severity: Critical. Recall number: Z-1396-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1396-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 2, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.