Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- Sedecal
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- SM-40HF-B-D-C, UDI/DI 08436046001510, G35524, G33711
- Sold at
- Unknown
- 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
Why This Is Dangerous
The device is not water-resistant, so improper cleaning could lead to potential safety or equipment integrity issues as outlined by the manual. This creates a high-risk scenario for users who fail to follow cleaning protocols.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to adjust cleaning procedures and monitor this equipment closely while awaiting remediation guidance.
Practical Guidance
How to identify if yours is affected
- Check model number SM-40HF-B-D-C
- Check UDI/DI 08436046001510
- Check serial numbers G35524 or G33711
- Confirm distribution in CA, IL, NJ
Where to find product info
Identifiers are on the equipment label and in the serial plate. The manual also lists cleaning requirements.
What timeline to expect
Remedies and replacements, if offered, typically take several weeks to complete.
If the manufacturer is unresponsive
- Document all attempts to contact Sedecal SA
- Escalate to the hospital compliance officer if needed
- File a consumer complaint with the FDA if the company is unresponsive
How to prevent similar issues
- Always follow the manual for cleaning and disinfection.
- Verify water exposure risks before any cleaning procedure.
- Maintain a log of cleaning events and updates from Sedecal
Documentation advice
Keep a copy of the recall notice and all correspondence with Sedecal SA. Photograph serial numbers and model labels.
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Product Details
Model numbers: SM-40HF-B-D-C; 40KW 55G/60G Sold to consignees in the United States (CA, IL, NJ) When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C; 40KW 55G/60G
- Not water-resistant; cleaning per manual required
- Distribution in CA, IL, NJ
- Active recall as of 2025-10-29
- No injuries reported
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Safety Guide
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