The Recall Desk

State

Florida product recalls

73,576 recalls have nationwide distribution and so reach Florida. 12,867 additional recalls listed Florida specifically in their distribution scope.

What the numbers show

Total
12,867
Critical
1,775
Severe
3,456
Most recent
2026-10-21

Of the 12,867 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 3,456 (27%) are Severe.

These figures cover only the 12,867 recalls whose distribution notice names Florida specifically. The 73,576 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

576–600 of 86443

  • HighFDA (Devices)·Z-3208-2026·2026-09-23

    Medline Recalls Minor Pack Convenience Kits Due to Open Sterile Seals

    Medline Industries is recalling 459 units of Minor Pack convenience kits because open sterile seals may compromise sterility and lead to patient infection.

    Product
    Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3137-2026·2026-09-23

    Medline Open Heart A Pack Kits Recalled for Sterility Concerns

    Medline is recalling 135 Open Heart A Pack kits in California due to a potential sterile barrier breach in the RCSP cannulae, posing a risk of infection.

    Product
    Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3175-2026·2026-09-23

    Happiest Baby SNOO Sleep Sack Recall for FDA Review Status

    Happiest Baby, Inc is recalling 1,055 units of SNOO Sleep Sacks because Extra Small and Extra Large sizes have not been reviewed for safety and effectiveness by the FDA.

    Product
    Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3198-2026·2026-09-23

    Howmedica Recalls Triathlon Hinge Inserts Due to Material Aging

    Howmedica is recalling Triathlon hinge inserts made with aged polyethylene that may wear excessively, potentially causing device fracture or the need for revision surgery.

    Product
    TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3164-2026·2026-09-23

    Nuclein DASH Rapid PCR Instrument Recalled for Software Issue

    Nuclein LLC is recalling 182 DASH Rapid PCR Instruments due to a software issue. The recall affects units distributed in 18 US states.

    Product
    Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3170-2026·2026-09-23

    GE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors

    GE Healthcare is recalling Workflow Core Services V8 because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3171-2026·2026-09-23

    GE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors

    GE Healthcare is recalling Core Services Hub V8 software because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3176-2026·2026-09-23

    Happiest Baby SNOO Sleep Sacks Recalled for Lack of FDA Review

    Happiest Baby, Inc. is recalling SNOO Sleep Sacks because they have not been reviewed for safety and effectiveness by the FDA.

    Product
    Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534 S2101-535 S2101-536 S2101-541 S2101-551 S2102-508-10 S2102-508-9 S2103-501…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3193-2026·2026-09-23

    Mirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure

    Mirion Technologies is recalling 783 Captus 4000e Thyroid Uptake Systems because a tension bolt may fail, causing the spring arm to fall unexpectedly.

    Product
    Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3212-2026·2026-09-23

    ICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage

    ICU Medical is recalling 185,688 CADD Yellow Medication Cassette Reservoirs because they may leak medication at the connector joint, potentially interrupting therapy or causing exposure to harmful agents.

    Product
    CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3179-2026·2026-09-23

    Embecta Medical Recalls Nano Pro Pen Needles Distributed as Commercial Devices

    Embecta Medical II LLC is recalling Nano Pro Un-Cannulated Demo Samples because investigational-use-only pen needles were inadvertently distributed as commercially marketed devices.

    Product
    EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3189-2026·2026-09-23

    Datex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect

    Datex-Ohmeda is recalling Aisys anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.

    Product
    Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3147-2026·2026-09-23

    Bayer Medical Care Recalls Stellant FLEX Syringe Kits Due to Sterilization Issues

    Bayer Medical Care is recalling 27,800 Stellant FLEX Syringe Kits because some may not have been properly sterilized due to a manufacturing issue.

    Product
    MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3167-2026·2026-09-23

    GE Healthcare Enterprise Archive V8 Software Recalled for Data Association Errors

    GE Healthcare is recalling Enterprise Archive V8 software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis.

    Product
    Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1386-2026·2026-09-23

    Best Friends Bakery Recalls Pumpkin Spice No Bake Cookies for Allergen Mislabeling

    Best Friends Bakery is recalling 1,416 units of Pumpkin Spice No Bake Cookies due to peanut and egg labeling errors.

    Product
    PUMPKIN SPICE NO BAKE COOKIE NET WT 3.5 oz. INGREDIENTS: WHOLE GRAIN OATS, MILK, MARGARINE***WATER, SALT, CONTAINS LESS THAN 2% OF THE FOLLOWING: SOY LECITHIN, VEGETABLE MONO & DIGLYCERIDES, POTASSIUM SORBATE***, CITRIC ACID, NATURAL & ARTIFICIAL FLAVOR, BETA CAROTENE, VITAMIN A…
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-3182-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3142-2026·2026-09-23

    Philips PIC iX Essentials Patient Information System Software Recall

    Philips North America is recalling 312 units of the PIC iX Essentials patient information system due to a software malfunction that may cause the system to freeze.

    Product
    Philips PIC iX Essentials REF:867093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3197-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components manufactured with aged polyethylene material that may oxidize and increase wear.

    Product
    ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3169-2026·2026-09-23

    GE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error

    GE Healthcare is recalling 116 Centricity PACS Server V7 systems because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3185-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3202-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implant Components Due to Material Aging

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made from aged polyethylene. The material may oxidize and wear excessively, potentially causing device failure.

    Product
    BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3168-2026·2026-09-23

    GE Healthcare Recalls Centricity PACS Software Due to Data Association Errors

    GE Healthcare is recalling Centricity PACS software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3166-2026·2026-09-23

    GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors

    GE Healthcare is recalling Centricity Enterprise Archive software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
    Category
    Medical Device
    Distribution
    Distributed nationwide