Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number…
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Read the official notice →- Date
- 2026-07-29
- Country
- United States
- Brand
- Paragon
- Product
- P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number…
- Classification
- Class II
- Units
- US nationwide, Australia, Canada, The Netherlands, and New Zealand
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Paragon recalls
- 2026-08-26
USParagon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
- 2025-12-10
- US
Paragon 28, Inc. recalls Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
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…
FDA · DeviceParagon 28, Inc.US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX,…Official notice → - 2024-03-13
- US
Paragon 28, Inc. recalls Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Medical devices distributed, prior to sterilization
- 2022-09-28
- US
Paragon 28, Inc. recalls Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
FDA · DeviceParagon 28, Inc.US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD,…Official notice → - 2022-08-03
- US
Paragon 28, Inc. recalls HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Due to Titanium plasma coating not present implant.
FDA · DeviceParagon 28, Inc.U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.Official notice → - US
Paragon 28, Inc. recalls Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Other drugs & medical recalls in the United States
- 2026-07-29
- US
Olympus Corporation of the Americas recalls Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying…
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
FDA · DeviceOlympus Corporation of the AmericasWorldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the…Official notice → - US
Ferno-Washington Inc recalls Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load,…
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and…
FDA · DeviceFerno-Washington IncWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, GA,…Official notice → - US
ICU Medical Inc. recalls Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's…
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
- US
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve…
- US
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
FDA · DeviceBoston Scientific CorporationInternational distribution in the countries of Italy, Austria, France,…Official notice → - US
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA · DeviceBoston Scientific CorporationInternational distribution in the states of Austria, Spain, France, Germany,…Official notice →