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
- REF 9890-010-89522, UDI/DI 08436046002357, SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080 +13 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
The MobileDiagnost wDR 2.2 is a portable X-ray system used by healthcare providers to perform radiographic imaging at patient bedsides or in transport.
Why This Is Dangerous
The device is not water-resistant. Cleaning must follow the manual. Improper cleaning could cause damage or complex operational issues as outlined by the manufacturer.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics using the device must review cleaning protocols and may experience downtime while awaiting remediation.
Practical Guidance
How to identify if yours is affected
- Check model REF 9890-010-89522 and serial numbers listed.
- Review if the unit was distributed to CA, IL, or NJ in the US.
- Verify your device against the recall notice and Sedecal instructions.
Where to find product info
On the device label, in the user manual, and the FDA recall page linked to the notice.
What timeline to expect
Not specified. Remediation steps depend on Sedecal instructions and regulatory guidance.
If the manufacturer is unresponsive
- Escalate to hospital risk management or procurement.
- Document all communications with Sedecal SA.
- File a consumer complaint with the FDA if needed.
How to prevent similar issues
- Do not use water or cleaning agents not approved by Sedecal for this device.
- Keep a copy of the recall notice with device records.
Documentation advice
Keep the recall notice, serial numbers, and all correspondence with Sedecal SA and healthcare providers.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- CA, IL, NJ distribution in the US
- Hazard: not water-resistant; improper cleaning could cause consequences
- Recall date 2025-06-10; status ACTIVE
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Safety Guide
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