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
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Distraction Pin
- Model numbers
- 301.914S2, All lots distributed from August 1, 2020, to July 30, 2025
- Sizes
- 14 mm
- Sold at
- Unknown
- 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
Frontier Devices produces specialized medical components such as distraction pins used in orthopedic procedures. These devices are Rx Only and sterile.
Why This Is Dangerous
An unvalidated shelf-life label can compromise product tracking and sterility assurances, potentially affecting device performance.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The recall prioritizes patient safety by halting use until shelf-life labeling is validated, with potential implications for sterility and inventory control.
Practical Guidance
How to identify if yours is affected
- Verify model 301.914S2 and UDI 00850014548032 on packaging
- Check distribution dates and lots: Aug 1, 2020 through Jul 30, 2025
- Confirm Rx Only and sterile labeling on product
Where to find product info
Visit the FDA enforcement page for recall Z-2580-2025 or contact the manufacturer
What timeline to expect
No timelines provided in notice; follow manufacturer instructions and FDA updates
If the manufacturer is unresponsive
- Document all communications
- Escalate to hospital risk management or patient safety office
- File FDA complaint if warranted
How to prevent similar issues
- Ensure future devices have validated shelf-life labeling
- Verify UDI codes and lot numbers
- Maintain up-to-date recall contact lists
- Choose suppliers with validated quality systems
Documentation advice
Keep copy of recall notice, packaging, and all correspondence; document lot numbers and serial numbers
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Product Details
Brand: Frontier Devices. Model: 301.914S2. Quantity: All lots distributed from Aug 1, 2020, to July 30, 2025. Size: 14 mm. Packaging: 10 double packs. Status: Active recall. Sold as Rx Only and sterile. UDI: 00850014548032. Distribution: United States nationwide (AL, CA, FL, GA, IL, MD, MI, PA, TX).
Reported Incidents
No specific injuries or incidents are described in the recall notice. The document indicates a labeling concern rather than a device malfunction causing injury.
Key Facts
- All lots recalled Aug 1, 2020 – Jul 30, 2025
- Shelf-life labeling not validated
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Safety Guide
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