CLASS II ONGOING Device recall · Reported 24 Sep 2025 · FDA Enforcement Report
Frontier Devices recalled by Folsom Metal Products
Folsom Metal Products is recalling Frontier Devices, distributed nationwide in the US. The recall was initiated on 21 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2579-2025
- FDA event ID
- 97480
- Recalling firm
- Folsom Metal Products, Pelham, AL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Aug 2025
- FDA classified
- 17 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Aug 2025 | Recall initiated by company | |
| 17 Sep 2025 | Classified by FDA | +27 days |
| 24 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling includes shelf life that has not been validated.
Product as listed by the FDA
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Where it was distributed
US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
Nationwide AlabamaCaliforniaFloridaGeorgiaIllinoisMarylandMichiganPennsylvaniaTexas
Questions about this recall
Why was it recalled?
Labeling includes shelf life that has not been validated.
Which lots are affected?
All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548032
Where was it sold?
US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97480This product is part of a recall event; the main page for the event is Frontier Devices recalled by Folsom Metal Products.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide | |
| CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide | |
| CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide | |
| CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide | |
| CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
More recalls from Folsom Metal Products
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |