The Recall Desk

State

Florida product recalls

72,820 recalls have nationwide distribution and so reach Florida. 12,816 additional recalls listed Florida specifically in their distribution scope.

What the numbers show

Total
12,816
Critical
1,763
Severe
2,974
Most recent
2026-09-06

Of the 12,816 recalls naming Florida we have scored against our rubric, 1,763 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,974 (23%) are Severe.

These figures cover only the 12,816 recalls whose distribution notice names Florida specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

801–825 of 85636

  • SevereFDA (Drugs)·D-0653-2026·2026-07-08

    IMULDOSA injection recalled due to lack of sterility assurance

    Accord BioPharma is recalling IMULDOSA (ustekinumab-srlf) Injection due to lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    IMULDOSA — IMULDOSA (USTEKINUMAB-SRLF)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2549-2026·2026-07-08

    Hillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall

    Baxter Healthcare Corporation is recalling the Hillrom VOLARA P.CIRCUIT 5KIT medical device due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and compromise medication delivery.

    Product
    Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2640-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking Failure Risk

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2550-2026·2026-07-08

    Hillrom VOLARA System patient circuits recalled for nebulizer leakage risk

    Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and prevent proper medication delivery.

    Product
    Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2621-2026·2026-07-08

    Preop Kit-NS surgical kits recalled for bacterial contamination

    A M S Preop Kit-NS surgical convenience kits are being recalled due to contamination with Paenibacillus phoenicis bacteria discovered during sterilization testing. The kits were distributed nationwide in PA, GA, CA, and WA.

    Product
    A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2605-2026·2026-07-08

    Omnipod Eros Pod Insulin Delivery Failure Risk

    Insulet Corporation is recalling Omnipod (Eros) Pod units due to external soft cannula damage during manufacturing that can cause insulin leakage instead of delivery to the user. High blood glucose levels and serious complications including diabetic ketoacidosis (DKA) or death may result from under-delivery of insulin.

    Product
    Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2551-2026·2026-07-08

    Hillrom VOLARA System patient circuits recalled for nebulizer cup leakage

    Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and ineffective medication delivery.

    Product
    Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0652-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2463-2026·2026-07-08

    Ventilator breathing circuit sets may obstruct exhalation valve

    Hamilton Medical AG is recalling coaxial breathing circuit sets used with three ventilator models because membranes may stick to the expiratory valve body, preventing proper gas exhalation and potentially causing inadequate ventilation.

    Product
    Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1137-2026·2026-07-08

    NARA ORGANICS Whole Milk Organic Infant Formula Recalled for Botulinum Contamination

    NARA ORGANICS Whole Milk Organic Infant Formula in 24.7 oz and 14.1 oz sizes is being recalled nationwide because the product may be contaminated with Clostridium botulinum.

    Product
    a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC: 8600
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0648-2026·2026-07-08

    ChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance

    CareFusion is recalling ChloraPrep One-Step antiseptic applicators because unsterilized units intended for further processing were distributed outside the intended channel, creating a sterility assurance gap.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0647-2026·2026-07-08

    ChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization

    CareFusion 213, LLC is recalling 7,650 units of ChloraPrep One-Step antiseptic applicators distributed nationwide because unsterilized product intended for further processing was distributed through incorrect channels.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2615-2026·2026-07-08

    Reprocessed Electrophysiology Catheters Recalled for Residual Particles

    Medline Industries is recalling reprocessed electrophysiology and ultrasound catheters with residual particles that may cause inflammation, infection, or blood clots if contacted with blood or the heart.

    Product
    Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0645-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0659-2026·2026-07-08

    Lidocaine Hydrochloride Injection Recalled for Sterility Assurance

    Asclemed USA Inc. is recalling Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL) in 5 mL single dose ampules nationwide due to lack of assurance of sterility. The affected lots have expiration dates of 11/30/2026 and 04/30/2028.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE ANHYDROUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0723-2026·2026-07-08

    Glucagon Emergency Kit Recalled for Manufacturing Process Deviation

    Lupin Pharmaceuticals is recalling Glucagon Emergency Kits (1mg) nationwide due to a manufacturing process deviation found during stability testing. The gliding force functionality test failed to meet specifications during 12-month testing.

    Product
    GLUCAGON — GLUCAGON (GLUCAGON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0676-2026·2026-07-08

    Cinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels

    Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2624-2026·2026-07-08

    Medtronic Harmony Delivery Catheter System Distal Tip Detachment Risk

    Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.

    Product
    Medtronic Harmony Delivery Catheter System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2632-2026·2026-07-08

    CRE Wireguided 6-8mm 240cm Medical Device Recall Worldwide

    Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.

    Product
    CRE Wireguided 6-8mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0644-2026·2026-07-08

    PurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall

    CareFusion 213, LLC is recalling PurPrep sterile applicators distributed nationwide because unsterilized units intended for further processing were distributed to customers outside the intended channel.

    Product
    PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0692-2026·2026-07-08

    Revitaderm Wound Care Gel recalled for microbial contamination

    Revitaderm Wound Care Gel has been recalled due to microbial contamination with Lysinibacillus fusiformis and other Bacillus species. The product was distributed nationwide and consumers should stop using it.

    Product
    Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2026·2026-07-08

    Surgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads

    Windstone Medical Packaging is recalling AMS Dr. Lewin Pack surgical convenience kits (45 units) distributed nationwide because they contain Webcol alcohol prep pads contaminated with Paenibacillus phoenicis bacteria.

    Product
    A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0651-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss

    CareFusion 213, LLC is recalling ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol applicators distributed nationwide because unsterilized units intended for further processing were distributed through the wrong channels.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0643-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2644-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking and Fall Hazard Recall

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems with the Xchange Robotic Collimator Changer because a collimator may fail to fully dock and fall from the housing if room-control pendant motion is initiated while the system interlock is bypassed.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide