Quick Facts at a Glance
- Recall Date
- November 12, 2025
- Hazard Level
- HIGH
- Brand
- Howmedica Osteonics
- 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
- Howmedica Osteonics
- Product type
- Surgical Device
- Model numbers
- Part Number: 6000-390-000, UDI-DI: 37613327097628, Lots: 6000106885, 6000106894, 6000106895, 6000106896
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 12, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Howmedica Osteonics Corp. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Stryker CranialMask Tracker is a surgical device used for patient tracking and mask registration during procedures. It provides essential functionality in surgical settings where precise tracking is necessary.
Why This Is Dangerous
The device's software malfunction leads to an error message that prevents activation, which is critical during surgical operations. This can delay or compromise medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects surgical practices that utilize this device, potentially causing delays in procedures and necessitating alternative tracking methods.
Practical Guidance
How to identify if yours is affected
- Check the part number on your device to see if it matches 6000-390-000.
- Verify the UDI-DI: 37613327097628.
Where to find product info
The part number and lot number can usually be found on the packaging or the device itself.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Contact the FDA if you do not receive a response.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Look for FDA approval and certifications when purchasing surgical devices.
Documentation advice
Keep a record of all communications with the manufacturer and any related receipts for your records.
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Product Details
The recalled product is the Stryker CranialMask Tracker, Part Number 6000-390-000. It is a single-use surgical device with an electronics control unit and infrared LEDs. The devices were distributed worldwide, including the US, Canada, Germany, Japan, and South Korea.
Key Facts
- Device displays error during surgery
- Immediate stop-use required
- Contact manufacturer for instructions
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