The Recall Desk

State

Florida product recalls

73,096 recalls have nationwide distribution and so reach Florida. 12,854 additional recalls listed Florida specifically in their distribution scope.

What the numbers show

Total
12,854
Critical
1,775
Severe
2,990
Most recent
2026-09-25

Of the 12,854 recalls naming Florida we have scored against our rubric, 1,775 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,990 (23%) are Severe.

Which agencies issued them

These figures cover only the 12,854 recalls whose distribution notice names Florida specifically. The 73,096 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8851–8875 of 85950

  • HighFDA (Devices)·Z-1005-2025·2025-01-29

    Medical Analyzer Software May Fail to Alert of Expired Reagent Packs

    The VITROS 5600 Integrated System's software (version 3.8.0 and higher) may fail to notify users when Signal Reagent Packs expire. This could result in use of expired reagents, causing no results or erroneous results from tests.

    Product
    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2025·2025-01-29

    HALYARD Laparotomy Surgical Pack Recalled for Additive Residue Contamination

    O&M HALYARD is recalling HALYARD Laparotomy Packs due to elevated residues of anti-block/slip additives found in the sterile packaging. These surgical instruments were distributed nationwide.

    Product
    Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1004-2025·2025-01-29

    BD PCR Cartridges for MAX System signal drift in select lots

    Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.

    Product
    BD PCR Cartridges used with MAX System. Model Number: 437519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0206-2025·2025-01-29

    First Aid Beauty Ultra Repair Cream Recalled for CGMP Deviations

    First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.

    Product
    First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2025·2025-01-29

    Dressing Change Kit Recalled Due to Package Integrity Concern

    Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2025·2025-01-29

    Randox Lipoprotein (a) assay distributed without required FDA clearance

    Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.

    Product
    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2025·2025-01-29

    Olympus Thunderbeat Hand Instrument Probe Tips May Break or Detach

    Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, sing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1013-2025·2025-01-29

    Wolf-Pak Dressing Change Kits Recalled Due to Package Defects

    Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0768-2025·2025-01-29

    Bodor P and C series laser cutting machines recalled for non-compliance

    Jinan Bodor Cnc Machine Co Ltd is recalling 269 units of Bodor P and C series laser cutting machines distributed nationwide due to non-compliance with FDA standards.

    Product
    Bodor P and C series laser cutting machines
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2025·2025-01-29

    Dressing change kits recalled due to packaging defect compromising sterility

    Trinity Sterile is recalling Dressing Change Kits with ChloraPrep and HaloGUARD due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed across multiple states.

    Product
    Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1003-2025·2025-01-29

    Olympus Thunderbeat Surgical Instruments Recalled for Probe Tip Damage

    Olympus is recalling Thunderbeat hand instruments (Model TB-0535FCS) because probe tips can be damaged or break during use. The recall affects 27,352 units distributed internationally.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: N5423810 Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1001-2025·2025-01-29

    Olympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking

    Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2025·2025-01-29

    Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips

    Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2025·2025-01-29

    Dressing Change Tray Recalled Due to Potential Package Sterility Compromise

    Trinity Sterile's Dressing Change Tray (Model TM6180CP, Lot 600032) is recalled because of a potential hole in the package that could compromise sterility. The recall affects 280 units distributed across Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2025·2025-01-29

    Olympus Thunderbeat Surgical Instrument Recalled for Damaged or Breaking Probe Tips

    Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2025·2025-01-29

    Olympus Thunderbeat Surgical Hand Instruments Recalled for Probe Damage

    Olympus Corporation is recalling Olympus Thunderbeat front-actuated surgical hand instruments (Model TB-0535FCS) due to damaged or breaking probe tips and pad detachment. Approximately 128,608 units distributed outside the US are affected.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1002-2025·2025-01-29

    Olympus Thunderbeat surgical instrument probe tips may damage or break

    Olympus is recalling Thunderbeat surgical hand instruments due to damaged or breaking probe tips that may occur during use and affect surgical procedure safety.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110¿ Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V041000·2025-01-29

    Kenworth and Peterbilt lighting switch failure disables hazard lights

    PACCAR is recalling certain 2023-2026 Kenworth and Peterbilt trucks because the exterior lighting switch may fail, leaving the hazard lights and instrument backlight brightness adjustment inoperative.

    Product
    KENWORTH — KENWORTH, PETERBILT T480, T380, T280, 548
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2025·2025-01-29

    CardioMEMS HF Pressure Measurement System Recalled for Inaccurate Readings

    St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.

    Product
    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2025·2025-01-29

    Repeater Bone Tamp Recalled for Component Incompatibility in Spinal Fusion

    Integrity Implants Inc. is recalling Repeater Bone Tamp devices (Model ASY-00132) due to incompatibility between Revision A bone tamps and Revision C bone funnels used in spinal fusion procedures.

    Product
    Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2025·2025-01-29

    Otological Ventilation Tubes recalled due to lack of FDA 510(k) clearance

    Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes (Product Code NZ3312-2) distributed in the US and internationally due to lack of FDA 510(k) regulatory clearance. The devices were distributed without required FDA pre-market approval.

    Product
    Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0979-2025·2025-01-29

    CODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions

    Integra LifeSciences is recalling 46 units of the CODMAN CERTAS Plus Programmable Valve due to incorrect product descriptions on internal and external labels. The affected devices were distributed nationwide across the U.S. and internationally.

    Product
    CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0965-2025·2025-01-29

    Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance

    Adept Medical Ltd is recalling 2,610 T-Tube 9mm otological ventilation tubes distributed without required FDA premarket 510(k) clearance. The affected silicone tubes were sold in the US and internationally.

    Product
    Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2025·2025-01-29

    Medtronic Arterial Cannula Recall Due to Incorrect Labeling

    Medtronic Perfusion Systems is recalling Select Series Angled Tip Arterial Cannulas (Model 72422) due to incorrect labeling. The recall involves 440 units distributed nationwide.

    Product
    Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
    Category
    Medical Device
    Distribution
    Distributed nationwide