Class IIOngoingZ-2330-2026
INSPIREMD Inc recalls CGuard¿ Prime Carotid Stent System
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
INSPIREMD IncFLJun 17, 2026
Recalls in Florida
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 52 recalls
Class IIOngoingZ-2329-2026
INSPIREMD Inc recalls CGuard Prime Carotid Stent System
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
INSPIREMD IncFLJun 17, 2026
Class IIOngoingZ-2328-2026
INSPIREMD Inc recalls Brand Name: CGuard Prime Carotid Stent System
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
INSPIREMD IncFLJun 17, 2026
Class IIOngoingZ-2327-2026
INSPIREMD Inc recalls CGuard Prime Carotid Stent System
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
INSPIREMD IncFLJun 17, 2026
Class IIOngoingZ-2326-2026
INSPIREMD Inc recalls Brand Name: CGuard¿ Prime Carotid Stent System
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
INSPIREMD IncFLJun 17, 2026
Class IIOngoingZ-2325-2026
INSPIREMD Inc recalls Brand Name: CGuard¿ Prime Carotid Stent System
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
INSPIREMD IncFLJun 17, 2026
Class IIOngoingZ-2280-2026
Fresh Roast Systems Inc recalls Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrar…
Fresh Roast Systems In…FLJun 17, 2026
Class IOngoingZ-2160-2026
Bolton Medical Inc. recalls RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-3…
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Bolton Medical Inc.FLJun 3, 2026
Class IIOngoingZ-2213-2026
Novapproach Spine, LLC recalls OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and…
Novapproach Spine, LLCFLMay 27, 2026
Class IIOngoingZ-2162-2026
Technological Medical Advancements LLC recalls Diowave Laser System
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local b…
Technological Medical…FLMay 20, 2026
Class IOngoingZ-1548-2026
Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucos…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
Trividia Health, Inc.FLMar 18, 2026
Class IOngoingZ-1547-2026
Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucos…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
Trividia Health, Inc.FLMar 18, 2026