Quick Facts at a Glance
- Recall Date
- December 4, 2025
- Hazard Level
- HIGH
- Brand
- Mobius Imaging
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 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
- Mobius Imaging
- Product type
- Computed Tomography (CT) X-ray System Component
- Model numbers
- Part No. MI-76-0237, UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX, Serial No. 2232206713, 2232206723, 2232206753, 2232206763, 2303430363, 2303430373 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 4, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mobius Imaging, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
The AIRO Computed Tomography (CT) X-ray System component is used in medical imaging to provide detailed internal views of patients. Healthcare providers rely on this equipment for accurate diagnostics and treatment planning.
Why This Is Dangerous
The lack of a "Safe Hand Position Warning" label can lead to improper use, increasing the risk of harm to both patients and healthcare providers. This labeling is essential for ensuring safe operation during use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate action from healthcare providers and could disrupt medical services depending on the availability of compliant replacement components.
Practical Guidance
How to identify if yours is affected
- Locate the model number and serial number on your AIRO pendant.
- Compare your pendant's details against the list of affected models and serial numbers provided in the recall notice.
- If your pendant matches, it is part of the recall.
Where to find product info
Serial numbers can typically be found on the device's label or user manual. Check the manufacturer's website for specific guidance on locating identifiers.
What timeline to expect
Expect a response regarding the recall instructions within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Mobius Imaging directly if you do not receive a timely response.
- Consider discussing the issue with your healthcare provider for additional support.
How to prevent similar issues
- When purchasing medical devices, ensure they have all necessary safety labels and certifications.
- Research the manufacturer's history concerning recalls and safety issues before making a purchase.
- Consult with industry professionals about the reliability and compliance of medical equipment.
Documentation advice
Keep records of your purchase, including receipts and correspondence with the manufacturer. Document any communications regarding the recall for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall affects 101 units of the detachable 10in Pend FRU-1 component for the AIRO Computed Tomography (CT) X-ray System. The affected model numbers include Part No. MI-76-0237 and several serial numbers ranging from 2232206713 to 2311019263. These units were distributed nationwide across various states including California, Texas, and New York.
Key Facts
- Recalled component: Detachable 10in Pend FRU-1 for AIRO CT X-ray System
- Quantity recalled: 101 units
- Hazard: Missing safety warning label
- Recall classification: Class II
- Recall date: December 4, 2025
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
