HIGH

Folsom Metal Products Recalls Distraction Pins Due to Labeling Issue

Folsom Metal Products recalled 10 double packs of 14 mm Distraction Pins on August 21, 2025. The recall affects devices with unvalidated shelf life labeling. Healthcare providers and patients must stop using these devices 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

Product Details

The recalled product is the 14 mm Distraction Pin, REF: 301.914S2. The recall includes all lots distributed from August 1, 2020, to July 30, 2025. These devices were distributed nationwide in states including Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, and Texas.

The Hazard

The recall stems from labeling that includes a shelf life that has not been validated. This presents a risk that the device may not perform as intended after an unspecified period.

Reported Incidents

There have been no reported incidents or injuries associated with the recalled distraction pins. The potential for misuse remains a concern due to the lack of validated shelf life.

What to Do

Patients and healthcare providers should immediately stop using the recalled distraction pins. Follow the recall instructions provided by the manufacturer and contact Folsom Metal Products for further guidance.

Contact Information

For more information, contact Folsom Metal Products, Inc. You can visit the official FDA recall page for additional details.

Key Facts

  • Recall date: August 21, 2025
  • Report date: September 24, 2025
  • Classification: Class II
  • Nationwide distribution in multiple states

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
301.914S2
All lots distributed from August 1, 2020, to July 30, 2025
UDI: 00850014548032
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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