Is this recall limited to Sedecal mobile X-ray systems?

Yes. The recall covers 12 units with model 40KWFXPLUS.005 and related identifiers listed by Sedecal. No injuries have been reported to date.

How can I check if my device is affected?

Review the model number and serial numbers listed in Sedecal's recall communications. Compare against your unit’s identifiers.

What does it mean that the device is not water-resistant?

It means water exposure could cause damage or safety concerns if cleaning is not performed exactly as described in the manual.

What should I do if I own one of these units?

Stop using the device immediately. Follow the manufacturer’s recall instructions and contact Sedecal SA or your healthcare provider for guidance.

Are there any injuries connected to this recall?

No injuries or incidents have been reported.” (*as of the recall notice*)

Is there a refund or replacement offered?

The recall notice does not specify refunds or replacements. Follow Sedecal's instructions for next steps.

How long will the recall process take?

The recall notice does not provide a timeline. Facilities should await further guidance from Sedecal.

Who should I contact for recall questions?

Contact Sedecal SA via the channel used to notify consignees or your healthcare provider for instructions.

Will this affect patient care?

Facilities should halt use of affected units until guidance is provided and implement recommended cleaning procedures.

What documentation should I keep?

Keep the recall notice, emails from Sedecal, unit identifiers, and any correspondence with providers.

How can I prevent this in the future?

Ensure cleaning procedures match the manual and verify device water-resistance specifications before cleaning.

Where can I find official recall records?

FDA enforcement pages and Sedecal communications are primary sources.

HIGHFDA DEVICEJune 10, 2025

Sedecal SA Recalls 12 Mobile X-ray Systems for Water-Resistance and Cleaning Risks (2025)

Sedecal SA recalled 12 mobile X-ray systems in the United States, including units distributed to California, Illinois and New Jersey. The devices are not water-resistant and must be cleaned strictly per the manual to avoid safety risks. Stop using the device immediately and follow the manufacturer’s recall instructions.

Official notice

Sedecal Health & Personal Care Medical Devices40KWFXPLUS.005UDI/DI 08436046002166G82576

Source-backed recall notice

No product image was available from the source feed.

Official source: FDA DEVICE
Recall date: June 10, 2025
Status: ACTIVE
Severity: 6/10

Quick Facts at a Glance

Recall Date: June 10, 2025
Hazard Level: HIGH
Brand: Sedecal
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 3 states
At-Risk Groups: GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

1Stop using the product until you confirm whether it is included in the recall.
2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand: Sedecal
Product type: Mobile X-ray System
Model numbers: 40KWFXPLUS.005, UDI/DI 08436046002166, G82576, G82871, G72391, G74872, G75722, G76782 +6 more
Sold at: Multiple Retailers
Where affected: CA, IL, NJ

Recall Timeline

Key dates and source checks for this recall record.

Recall announced
June 10, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.

Hazard Information

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail

About This Product

This is a mobile X-ray system used in hospitals and clinics to perform bedside radiography and imaging. It is designed for use in patient care environments.

Why This Is Dangerous

The device is not water-resistant. Cleaning must follow the manual. Improper cleaning could cause device damage or safety risks for patients and operators.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Facilities with affected units must stop use and follow manufacturer instructions. The recall affects 12 units across CA, IL, and NJ. No injuries reported yet.

Practical Guidance

How to identify if yours is affected

1) Check if your unit matches model 40KWFXPLUS.005 or listed identifiers.
2) Confirm if your device was distributed to CA, IL, or NJ.
3) Review the recall email and manufacturer instructions.

Where to find product info

FDA recall page Z-0249-2026 and Sedecal communications. Unit identifiers include UDI/DI 08436046002166 and serials like G82576, G82871, G72391, etc.

What timeline to expect

No timeline is provided for refunds or replacements. Follow Sedecal instructions for next steps.

If the manufacturer is unresponsive

Document all communications with Sedecal and healthcare providers.
Escalate to the facility's compliance or risk management team.
Consider consulting legal counsel if the manufacturer is unresponsive and safety risk persists.

How to prevent similar issues

Verify device water-resistance specifications before cleaning the next time.
Ask vendors for written cleaning guidance and update procedures accordingly.

Documentation advice

Keep recall notices, emails, serial numbers, model numbers, and all correspondence with Sedecal and providers for records.

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Product Details

Model: 40KWFXPLUS.005. Location: United States (CA, IL, NJ). Recall date: 2025-06-10. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Distributed to CA, IL, NJ
Not water-resistant; cleaning per manual
No injuries reported

View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

6/ 10

Affected Groups

GENERAL

Jun 10, 2025

Sedecal

Sedecal sent