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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

11626–11650 of 13802

  • HighFDA (Devices)·Z-1275-2022·2022-06-29

    EVIS EXERA II Gastrointestinal Videoscope Recalled for Incorrect Component Fit

    Olympus is recalling 8 EVIS EXERA II gastrointestinal videoscopes (Model GIF-HQ190) because an incorrect rubber component may have been installed during repair. The incorrect part does not meet the device's design specifications.

    Product
    EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2022·2022-06-29

    FDA Recalls Catheter Drainage Kits With Wrong Needle Size

    Bard Peripheral Vascular Inc is recalling certain catheter drainage kits that may contain an 8 Fr needle instead of the correct 6 Fr needle. The incorrect needle size could cause tissue injury during patient care.

    Product
    REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2022·2022-06-29

    Cardiac device software recalled for inadequate electrical insulation

    CardioTek EP-TRACER Software V2.x is recalled because it failed electrical safety testing for insulation. The 146 affected units were distributed worldwide.

    Product
    CardioTek EP-TRACER Software V2.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1211-2022·2022-06-22

    Drager SafeStar 55 Medical Devices Recalled for Possible Filter Occlusion

    Draeger Medical is recalling approximately 35,950 Drager SafeStar 55 medical devices due to a manufacturing error that may cause occlusion of the device's filters, potentially preventing proper device function.

    Product
    Drager SafeStar 55, Catalog No. MP01790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2022·2022-06-22

    Philips OmniWire guide wire recalled for potential sterilization failure

    Volcano Corp is recalling 11 Philips OmniWire Pressure guide wires distributed in Washington, Wisconsin, and Canada due to a potential failed sterilization process.

    Product
    Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1267-2022·2022-06-22

    Medtronic Cobalt ICD and CRT-D Telemetry Software Error Recall

    Medtronic is recalling Cobalt and Crome ICDs and CRT-Ds due to a software telemetry error in the CareLink SmartSync Device Manager. The error may affect device communication and remote monitoring.

    Product
    Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2022·2022-06-22

    Tandem t:slim X2 Insulin Pump Battery Display May Cause Insulin Delivery Failure

    Tandem t:slim X2 insulin pumps may display inaccurate battery levels, risking insulin delivery failure if the battery depletes unexpectedly. Users should maintain battery above 25% to prevent unintended insulin cessation.

    Product
    t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1268-2022·2022-06-22

    Medtronic Crome and Cobalt Cardiac Defibrillators Recalled Due to Telemetry Error

    Medtronic recalls 3,944 Crome and Cobalt ICDs and CRT-Ds due to a potential telemetry error affecting device communication with external monitors.

    Product
    Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1261-2022·2022-06-22

    FDA Recalls Axium Detachable Coil Systems for Incorrect Labeling

    Micro Therapeutics is recalling Axium Detachable Coil Systems due to incorrect size and configuration labeling. The 96 affected units were distributed to China and the Republic of Korea.

    Product
    AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1263-2022·2022-06-22

    Olympus Uretero-Reno Fiberscope Recalled for Defective Adhesive and Vision Loss

    The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is recalled for incorrect adhesive securing the diopter ring. The defect may cause loss of adjustment function, blurred vision, and in rare cases, urinary tract perforation.

    Product
    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1260-2022·2022-06-22

    Illumina NextSeq 550 Genetic Sequencer Cybersecurity Vulnerability Recall

    Illumina is recalling 799 NextSeq 550 Dx genetic sequencers due to a cybersecurity vulnerability in the Local Run Manager software. Affected devices have been distributed worldwide and in the United States.

    Product
    illumina Model NextSeq 550 Dx REF 20005715
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2022·2022-06-22

    Olympus Fiberscope Recalled for Defective Diopter Ring Adhesive

    Olympus URETERO-RENO FIBERSCOPE Model URF-P6R recalled due to incorrect adhesive securing the diopter ring, which may cause loss of focus and in rare cases urinary tract perforation.

    Product
    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1265-2022·2022-06-22

    GE CARESCAPE Central Station power supply failure recall

    GE Healthcare is recalling CARESCAPE Central Station V2 patient monitoring devices due to potential power supply failure that can cause device shutdown and loss of patient monitoring.

    Product
    CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2022·2022-06-22

    Illumina MiSeq Dx Sequencing Instruments Recalled Due to Cybersecurity Vulnerability

    Illumina is recalling approximately 1,014 MiSeq Dx sequencing instruments due to a cybersecurity vulnerability. The devices are distributed worldwide and throughout the United States.

    Product
    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2022·2022-06-22

    Olympus endoscope diopter ring adhesive failure may impair vision

    Olympus endoscopes with defective diopter ring adhesive may cause vision loss and, in rare cases, urinary tract perforation.

    Product
    Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1227-2022·2022-06-15

    Ventilator Backup Battery Failure Recalled by GE Healthcare Worldwide

    GE Healthcare is recalling backup batteries for ventilators used in critical care. The batteries may not provide sufficient backup power when disconnected from AC, potentially causing unexpected device shutdown.

    Product
    Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1207-2022·2022-06-15

    HeartWare HVAD Pump Implant Kit recalled for welding defect risk

    Medtronic is recalling HeartWare HVAD Pump Implant Kit units due to a welding defect in the center post cap that can lead to pump malfunction and affect blood flow.

    Product
    HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1226-2022·2022-06-15

    GE Healthcare Ventilators Recalled for Insufficient Battery Backup Power

    GE Healthcare is recalling multiple ventilator models due to insufficient battery backup power. The affected units may shut down prematurely when not connected to AC power.

    Product
    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2022·2022-06-15

    Centricity Cardiology CA1000 may display inaccurate distance and area measurements

    GE Healthcare is recalling the Centricity Cardiology CA1000 software due to potential inaccurate distance and area measurements on magnified or scaled-down images, which could affect diagnostic accuracy.

    Product
    Centricity Cardiology CA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2022·2022-06-15

    Endoscope models recalled for image loss during electrocautery activation

    Karl Storz endoscope models may lose image when monopolar electrocautery is activated. The recall affects 401 units distributed to hospitals in 33 U.S. states and Canada.

    Product
    STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2022·2022-06-15

    Cook Nester Embolization Microcoil recalled for unintended cannula defect

    Cook Incorporated recalls Nester Embolization Microcoil devices whose loading cartridges may contain an unintended stainless-steel cannula. Affected devices were distributed domestically and worldwide.

    Product
    Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2022·2022-06-15

    Hilal Embolization Microcoils Recalled for Unintended Stainless-Steel Cannula

    Cook Incorporated is recalling Hilal Embolization Microcoils because their loading cartridges may contain an unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide and internationally.

    Product
    Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2022·2022-06-15

    Getinge CM320-2 Surgical Instrument Washer Disinfector Recalled for Incomplete Installation Verification

    Getinge recalls its CM320-2 washer disinfector due to unverified or incomplete installation, which could cause skin burns, electric shock, smoke inhalation, or crush injuries. Four units were distributed across seven US states.

    Product
    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2022·2022-06-15

    Triathlon Tritanium Tibial Components Recalled for Size-Packaging Mismatch

    Howmedica Osteonics is recalling specific lots of Triathlon Tritanium Tibial Components (knee implants) due to a potential mismatch between package labeling and the actual component size contained inside.

    Product
    Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
    Category
    Medical Device
    Distribution
    Distributed nationwide