Frontier Devices Distraction Pins Recalled for Unvalidated Shelf Life Labeling
Folsom Metal Products is recalling Frontier Devices 14 mm Distraction Pins because the labeled shelf life has not been validated. The recall affects products distributed nationwide from August 2020 through July 2025.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a labeling error on a sterile medical device classified as FDA Class II. No illnesses or injuries have been reported. The hazard is theoretical and depends on whether actual shelf life differs from the label.
Plain-English summary
Folsom Metal Products is recalling Frontier Devices REF: 301.914S2, 14 mm Distraction Pins (supplied in 10 double packs) because the labeling includes a shelf life that has not been validated. The affected lots were distributed nationwide from August 1, 2020, through July 30, 2025, to facilities in Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, and Texas.
An unvalidated shelf life on a sterile medical device presents a potential safety concern. If the actual shelf life is shorter than labeled, the device could be used beyond its safe lifespan, potentially compromising sterility or device function.
Customers who have received these products should contact Folsom Metal Products or consult the FDA recall notice (Z-2580-2025) for guidance on handling affected inventory.
The recalled product
- Product
- Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
- Manufacturer
- Folsom Metal Products, Inc.
- Hazard
- unvalidated-shelf-life
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- All lots distributed from August 1
- 2020
- to July 30
- 2025/UDI: 00850014548032
Distribution
Distributed nationwide across the United States.
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