Paragon 28 recalled 20 Phantom Fibula Nails nationwide after finding out-of-spec thread depths. The defect may prevent the nail from mating properly with the mounting bolt. Surgery could be aborted if the implant cannot mate with instrumentation. Hospitals and surgeons should stop using the device immediately and follow recall instructions.
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
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: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Fibula nails are implanted to fix fibular fractures or perform osteotomies. The Phantom Fibula Nail by Paragon 28 is titanium and designed for use in orthopedic surgery.
Out-of-spec thread depths may prevent proper mating with the mounting bolt. If the nail cannot mate with instrumentation, the surgery potentially will be aborted and the procedure may need to be redone.
This recall is not stated as part of a broader industry pattern.
Clinicians may need to alter surgical plans or abort procedures. No injuries or incidents have been reported to date.
See FDA recall page linked in notice for official instructions. Manufacturer contact is Paragon 28, Inc.
No specific replacement timeline provided. Follow manufacturer and healthcare provider instructions.
Retain the recall notification letter, document unit numbers and lot numbers, keep correspondence with providers and manufacturers.
Model numbers: UDI-DI 00889795133670. Lot: 501182207125. Expiration: March 13th. Additional model: 2030. Distribution: US nationwide in NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. Manufacturer: Paragon 28, Inc. Recall date: 2025-10-13. Status: ACTIVE. Quantity: 20.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.
ZOLIQUEX recalled adult portable bed rails sold on Amazon after reports of entrapment and asphyxiation risk. The recall targets silver bed rails measuring 12.4 inches wide by 33.07 inches tall and weighing 7.1 pounds. The model numbers ZEX014-V1 and the Zoliquex branding appear on packaging. Stop using the product and seek a full refund by contacting ZOLIQUEX.
Vitaquest International recalled Arey Not Today iron supplements sold at retailers nationwide after determining the products do not meet the Poison Prevention Packaging Act's child-resistant packaging requirement. The noncompliant packaging creates a poisoning risk to young children if ingested. Consumers should stop using the products immediately and contact Vitaquest for a free child-resistant替换
Easymake adult portable bed rails imported by ZFZG-US are recalled on April 9, 2026. The recall cites a risk of entrapment and asphyxiation and notes the product lacks required hazard warning labels. Stop using the recalled rails immediately and contact ZFZG-US for a full refund.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Sangohe expands its 2026 recall of adult portable bed rails 504E and 504Q due to entrapment and asphyxiation risk. The recall cites noncompliance with the mandatory standard and missing warning labels. Stop using the recalled rails and pursue a full refund by contacting Sangohe.
Tuymec Minoxidil Hair Growth Kit sold on Amazon by DrHealBeauty is recalled for non-child-resistant packaging. The kit contains two black spray bottles with 5% minoxidil and BIOTIN labels. Consumers should stop using the product immediately and contact DrHealBeauty for a free empty replacement bottle with a child-resistant closure.
TecFlox recalled its Minoxidil Topical Solution hair growth serum bottles on April 2, 2026. The packaging is not child-resistant, violating the Poison Prevention Packaging Act. Consumers should stop using the product immediately, store it out of reach of children, and email TecFloxrecall@outlook.com to receive free replacement bottles. Only bottles with serum remaining will be replaced; dispose of