Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 11, 2026
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy th
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and…
The recall
Olympus Corporation of the Americas issued this moderate-severity FDA Devices recall — Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase ….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- March 11, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1478-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1478-2026) was formally reported on March 11, 2026, with the manufacturer initiating the action on November 14, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Olympus Corporation of the Americas is listed as the recalling firm, operating out of Center Valley, PA. Federal records list the affected scope as 1082 units.
The documented reason for this recall is: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Affected scope
1082 units
Related Recalls
6
6 from same agency
Product description
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Reason for recall
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1478-2026 |
| Date reported | March 11, 2026 |
| Date initiated | November 14, 2025 |
| Recalling firm | Olympus Corporation of the Americas |
| Firm location | Center Valley, PA |
| Affected scope | 1082 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. |
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-1478-2026) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.. Recalled by Olympus Corporation of the Americas. Units affected: 1082 units.
Why was this product recalled? ▼
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2026. Severity: Moderate. Recall number: Z-1478-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1478-2026) 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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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 11, 2026.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.