Quick Facts at a Glance
- Recall Date
- August 21, 2025
- Hazard Level
- HIGH
- Brand
- Folsom Metal Products
- 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
- Folsom Metal Products
- Product type
- Medical Pin
- Model numbers
- 301.914S1
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 21, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling includes shelf life that has not been validated.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Folsom Metal Products, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The 301.914S1 Distraction Pin is used in medical settings for various surgical procedures. Consumers purchase it due to its necessity in care protocols that require precise instruments.
Why This Is Dangerous
The unvalidated shelf life means that patients might use a device that is less effective or entirely ineffective, potentially compromising treatment outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall affects patient safety directly as it risks the use of ineffective medical devices.
Practical Guidance
How to identify if yours is affected
- Check the product packaging for model number 301.914S1.
- Verify if the labeling includes unvalidated shelf life information.
- Look for recall notifications from healthcare providers.
Where to find product info
The model number and shelf life information can typically be found on the packaging or the manufacturer's informational inserts.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing.
If the manufacturer is unresponsive
- Document all communication attempts with Folsom Metal Products.
- File a complaint with the FDA if you do not receive assistance.
How to prevent similar issues
- Always check for updated recalls before using medical devices.
- Verify shelf life and validation of products when purchasing.
Documentation advice
Keep receipts, correspondence, and any relevant documentation regarding the recall.
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Product Details
Product: 301.914S1 Distraction Pin Quantity: 10,960 units Prescription Type: Rx Only Distribution: US Nationwide in AL, CA, FL, GA, IL, MD, MI, PA, TX Recall Date: August 21, 2025
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Labeling lacks validated shelf life information
- Class II device
- Affected states: AL, CA, FL, GA, IL, MD, MI, PA, TX
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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