The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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8426–8450 of 40056

  • HighFDA (Devices)·Z-0679-2024·2024-01-17

    Gamma Camera Recalls Due to Potential Patient Extremity Entrapment Hazard

    Philips BrightView XCT gamma cameras may pose an extremity entrapment hazard during certain scanning operations. A gap can form between the patient support and detector, risking fractures, lacerations, and crush injuries.

    Product
    BrightView XCT, Gamma Camera, Product Code 882482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0714-2024·2024-01-17

    Ambu aView 2 Monitor recalled for fire and burn hazard from oversized mounting screws

    Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.

    Product
    Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0641-2024·2024-01-17

    Medical diagnostic reagent recall: incorrect cell staining fluorescence

    BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.

    Product
    CD11b APC: ASR, REF: 340936, and CE, REF: 333143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2024·2024-01-17

    Bard Mission Biopsy Instrument Kits Recalled for Improper Needle-Cannula Fit

    Bard is recalling Mission Disposable Core Biopsy Instrument Kits due to dimensional issues that may prevent the biopsy needle from fitting properly into the cannula, potentially causing tissue injury and prolonging procedures.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2024·2024-01-17

    Olympus ENDOEYE Flex Videoscope Recalled for Reprocessing Instruction Deviations

    Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.

    Product
    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0698-2024·2024-01-17

    Medtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects

    Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.

    Product
    Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2024·2024-01-17

    XScribe Cardiac Stress Testing System may distort ECG readings

    Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to potential distortion in electrocardiogram readings when the Source Consistency Filter is enabled. No injuries have been reported.

    Product
    XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0670-2024·2024-01-17

    Townsend Design Custom SPRYSTEP Ankle-Foot Orthosis Recalled for Structural Failure Risk

    Townsend Design is recalling 248 units of CUSTOM SPRYSTEP ankle-foot orthotics for potential air pockets that could cause complete structural failure and loss of ankle support.

    Product
    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0654-2024·2024-01-17

    Abiomed Introducer Kits recalled due to sterile barrier compromise

    Abiomed is recalling Introducer Kits because holes in the outer pouch may compromise the sterile barrier, risking bacterial infection. The kits are distributed nationwide and internationally.

    Product
    Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0664-2024·2024-01-17

    Peri-Guard Repair Patch marketing brochure contains inaccurate information

    Baxter Healthcare recalls a marketing brochure for Peri-Guard Repair Patch because it contains inaccurate information that does not match the product's Instructions for Use.

    Product
    Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, TS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0708-2024·2024-01-17

    Robotic Drill Recall: Users Unable to Resolve Disconnection Errors

    Blue Belt Technologies is recalling 1,859 CORI REAL INTELLIGENCE Robotic Drills (models ROB10013 and ROB10013S) because users cannot resolve drill disconnection error messages. No illnesses or injuries have been reported.

    Product
    CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0674-2024·2024-01-17

    Cordis MYNXGRIP 5F Vascular Closure Device Carton Labeling Error

    Cordis US Corp is recalling MYNXGRIP 5F vascular closure devices due to incorrect labeling on carton boxes. The carton labels between two lots were swapped; however, the individual device labels remain correct.

    Product
    MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0690-2024·2024-01-17

    Cysto-Nephro Videoscope Model CYF-VHR: Reusable Brush Cleaning Instructions Updated

    Olympus updated cleaning instructions for the Model CYF-VHR Cysto-Nephro Videoscope. Reusable brushes have been removed from manual cleaning procedures; single-use brushes remain compatible.

    Product
    Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0686-2024·2024-01-17

    FDA updates cleaning instructions for EVIS EXERA III bronchovideoscope

    Shirakawa Olympus has updated cleaning instructions for the EVIS EXERA III bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; single-use brushes remain compatible.

    Product
    Model No. BF-P190, EVIS EXERA III Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0688-2024·2024-01-17

    FDA Recalls Rhino-Laryngofiberscope Cleaning Instructions for Brush Compatibility

    Shirakawa Olympus is recalling instructions for the Model ENF-XP Rhino-Laryngofiberscope. Reusable cleaning brushes have been removed from the manual cleaning procedure; single-use brushes remain compatible.

    Product
    Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0662-2024·2024-01-17

    Baxter FloSeal Hemostatic Matrix Recalled for Marketing Brochure Inaccuracies

    Baxter Healthcare Corporation is recalling Baxter FloSeal Hemostatic Matrix RECOTHROM products because the marketing brochure contains inaccurate information that does not align with the product's official Instructions for Use and Prescribing Information.

    Product
    Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0665-2024·2024-01-17

    Peri-Guard Repair Patch Recall Due to Inaccurate Marketing Brochure

    Baxter Healthcare recalls Peri-Guard Repair Patch due to cardiovascular surgery marketing brochure containing inaccurate content that does not align with the product's Instructions for Use.

    Product
    Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0684-2024·2024-01-17

    Model CYF-5 cystonephrofiberscope cleaning instructions updated by Olympus

    Shirakawa Olympus has updated cleaning instructions for the Model CYF-5 cystonephrofiberscope, removing reusable cleaning brushes from the manual cleaning protocol while single-use brushes remain compatible.

    Product
    Model No. CYF-5, Cystonephrofiberscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2024·2024-01-17

    Marketing brochure for Baxter Floseal hemostatic device contains inaccurate content

    Baxter Healthcare is recalling a cardiovascular surgery marketing brochure for Baxter Floseal Hemostatic Matrix Fast Prep because it contains inaccurate content that does not match the official product instructions and prescribing information.

    Product
    Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0667-2024·2024-01-17

    Baxter FloSeal Hemostatic Matrix brochure contains inaccurate clinical information

    A Baxter marketing brochure for FloSeal Hemostatic Matrix contains inaccurate content that does not match the product's official Instructions for Use and Prescribing Information.

    Product
    Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0657-2024·2024-01-17

    Baxter Coseal Premix Surgical Sealant: Marketing Brochure Information Inaccuracy

    Baxter Healthcare Corporation is recalling Coseal Premix Surgical Sealant due to inaccurate information in a marketing brochure that conflicts with the product's Instructions for Use and Prescribing Information.

    Product
    Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0668-2024·2024-01-17

    Baxter PERI-GUARD SUPPLE marketing brochure contains inaccurate instructions

    Baxter Healthcare Corporation is recalling PERI-GUARD SUPPLE surgical devices because the marketing brochure contains inaccurate content that does not align with the products' actual Instructions for Use.

    Product
    PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0687-2024·2024-01-17

    Bronchovideoscope Manual Cleaning Updated: Reusable Brushes No Longer Approved

    Olympus has updated cleaning instructions for the EVIS EXERA III Bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; only single-use brushes should be used.

    Product
    Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0712-2024·2024-01-17

    QMS Tacrolimus Calibrators Recalled for Quality Degradation from Improper Storage

    Ortho-Clinical Diagnostics is recalling QMS Tacrolimus Calibrators Lot 74859619 due to improper storage that degrades product quality, potentially causing erroneous test results and testing delays.

    Product
    QMS Tacrolimus Calibrators, Product code 10015573
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0692-2024·2024-01-17

    Videoscope Cleaning Instructions Updated: Reusable Brushes No Longer Compatible

    Shirakawa Olympus updated cleaning instructions for VISERA Cysto-Nephro Videoscopes, recommending removal of reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.

    Product
    Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide