HIGH

Folsom Metal Products Recalls Distraction Pins Due to Labeling Issues

Folsom Metal Products recalled 2,700 units of distraction pins on August 21, 2025. The recall affects devices with unvalidated shelf life labeling. Patients and healthcare providers must stop using the product immediately.

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

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

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Product Details

The recall includes Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin sold in 5 single packs. The affected units were distributed nationwide in the U.S. from August 1, 2020, to July 30, 2025.

The Hazard

The recall stems from unvalidated shelf life labeling. Use of such devices could lead to ineffective treatment.

Reported Incidents

There are no reported incidents or injuries associated with this recall at this time. The recall is classified as Class II, indicating a potential for temporary health issues.

What to Do

Stop using the device immediately. Contact Folsom Metal Products or your healthcare provider for further instructions.

Contact Information

For more information, visit the FDA website or contact Folsom Metal Products directly. Recall notification was sent via letter.

Key Facts

  • Recall date: August 21, 2025
  • 2,700 units recalled
  • Rx Only, Sterile devices
  • Distribution includes AL, CA, FL, GA, IL, MD, MI, PA, TX

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
REF: 301.914S1
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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