Quick Facts at a Glance
- Recall Date
- June 17, 2026
- Hazard Level
- HIGH
- Brand
- Paragon 28
- Geographic Scope
- 1 states
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
- Paragon 28
- Model numbers
- UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225, UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225, UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725, UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925 +2 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 17, 2026
Reported by FDA DEVICE
July 29, 2026
RecallRadar source check
August 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Paragon 28, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Get instant alerts for Paragon 28 recalls
Be the first to know. Free instant alerts to your inbox.
Full Description
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.. Reason: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.. Classification: Class II. Quantity: 514 units. Distribution: US nationwide, Australia, Canada, The Netherlands, and New Zealand
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
Get instant alerts for recalls that affect you. Free forever.