Quick Facts at a Glance
- Recall Date
- August 21, 2025
- Hazard Level
- HIGH
- Brands
- Frontier Devices, 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
- Frontier Devices, Folsom Metal Products
- Product type
- 14 mm Distraction Pin
- Model numbers
- REF: 301.914S1
- Sizes
- 14 mm
- 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 device is a 14 mm distraction pin used in orthopedic procedures. It is labeled Rx Only and shipped sterile. The recall concerns shelf-life labeling rather than the device’s functional integrity.
Why This Is Dangerous
If shelf life labeling is not validated, there is a potential risk that the device may be used outside validated expiry or storage conditions, compromising sterility or performance.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinicians must identify affected devices and follow recall instructions to avoid using non-validated labeled sterile devices.
Practical Guidance
How to identify if yours is affected
- Verify if your device label shows REF 301.914S1.
- Check for shelf-life validation statements on the labeling.
- Cross-check against the recall notice and letter from the manufacturer.
Where to find product info
Label on the device packaging shows REF 301.914S1. Recall details available on the FDA enforcement page linked in the notice.
What timeline to expect
Replacement or disposal instructions will be provided by the manufacturer; processing timelines vary, often several weeks.
If the manufacturer is unresponsive
- Escalate to hospital or practice risk management
- File a report with the FDA if advised by the manufacturer or regulator
How to prevent similar issues
- Always verify shelf-life validation on sterile devices before use.
- Maintain updated recall monitoring for medical devices through FDA channels.
- Document lot numbers and labeling for all sterility-critical devices.
Documentation advice
Keep the recall letter, take photos of the device label, record model and lot information, and save all communications with the manufacturer.
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Product Details
Model: REF: 301.914S1. Distribution: US nationwide in AL, CA, FL, GA, IL, MD, MI, PA, TX. Recall date: 2025-08-21. Report date: 2025-09-24. Quantity: 2,700 units. Price: Unknown. Manufacturer/Distributor: Frontier Devices; Distributor/Manufacturer contact: Folsom Metal Products, Inc.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model REF: 301.914S1
- Shelf-life labeling not validated
- Rx Only, Sterile
- US nationwide distribution in 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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