State
20,189 recalls have nationwide distribution and so reach Florida. 0 additional recalls listed Florida specifically in their distribution scope.
Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Florida consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.
If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.
Merit Medical Systems is recalling basixTOUCH Inflation Devices due to a potential hole in the sterile barrier. The defect may expose patients to pathogens and pyrogens, increasing infection risk.
BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.
Boston Scientific AVVIGO+ Multi-Modality Guidance System displays incorrect grid overlay when connected to OptiCross 18 catheters in Live or Record mode due to a software anomaly. The wrong overlay could affect reference depth settings used in vascular imaging procedures.
Boston Scientific is recalling 5 units of its AVVIGO+ Guidance System due to a software error that displays an incorrect grid overlay when connected to OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.
Rugby Laboratories is recalling First Aid Antiseptic (Povidone-Iodine 10%) ointment because the product contains undeclared inactive ingredients not listed on the label.
Medline Industries is recalling 15 kits of MEDLINE HEART CABG DLP Vessel Cannulae due to incorrect model labeling discovered during manufacturing.
Merit Medical Systems is recalling Blue Diamond Digital Inflation Devices due to potential sterile barrier defects. Affected devices may have small holes that could allow exposure to pathogens, creating infection risk.
Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.
Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.
The Boston Scientific AVVIGO+ Guidance System displays an incorrect grid overlay when used with the OptiCross 18 catheter in Live or Record mode, potentially affecting depth reference settings. No injuries have been reported.
Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.
Boston Scientific is recalling AVVIGO+ systems due to a software anomaly that displays an incorrect grid overlay when connected to OptiCross 18 catheters, potentially leading to vessel imaging misinterpretation.
Leica Biosystems is recalling the Cryostat Model CM1950 due to missing warnings about using flammable freezing sprays in the device. Flammable sprays can ignite inside the chamber, potentially causing serious injuries.
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software anomaly that displays a 9-grid overlay instead of the correct 15-grid overlay during Live and Record modes. This incorrect display could affect imaging measurements during procedures.
Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.
Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.
Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.
Nova Ortho-Med is recalling 1,886 MONARCH ROLLATOR BLUE rolling walkers due to a potential fall hazard. The backrest may disengage when users shift from a slouched to upright seated position.
Leica cryostat units lack a warning about flammable freezing sprays that can ignite in the chamber. The company discovered through post-market surveillance that users were applying these flammable sprays without being warned of the fire hazard.
Nova Ortho-Med is recalling the MONARCH ROLLATOR PURPLE due to a fall hazard: the backrest may disengage when users shift from a slouched to upright seated position.
Pending LLM rewrite. Source: FDA_DEVICE Z-0107-2025.
Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.
Horizon Cardiology Hemo Version 12.2 is recalled for a unit-of-measurement configuration issue that can produce incorrect hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. The recall affects 3 worldwide systems.
Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.
Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.