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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10176–10200 of 27470

  • HighFDA (Devices)·Z-0751-2022·2022-03-23

    Boston Scientific Sphincterotome Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 21,309 units of the Dreamtome RX Cannulating Sphincterotome due to a sterile barrier breach that compromises device sterility, creating a potential infection risk to patients.

    Product
    Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2022·2022-03-23

    Boston Scientific DREAMTOME medical devices recalled for sterile barrier breach

    Boston Scientific is recalling 982 units of DREAMTOME medical devices due to sterile barrier breach that compromises device sterility. Affected units were distributed worldwide.

    Product
    DREAMTOME 49-20MM/260CM Material Number: M00584000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2022·2022-03-23

    Boston Scientific DREAMTOME device recalled due to sterile barrier breach

    Boston Scientific is recalling 12,067 DREAMTOME devices worldwide due to compromised sterility from a sterile barrier breach. The affected units may not be properly protected from contamination.

    Product
    DREAMTOME 44-30MM/260CM Material Number: M00584050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2022·2022-03-23

    Boston Scientific RX Cholangiogram Kit Recall Due to Sterile Barrier Breach

    Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.

    Product
    RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2022·2022-03-23

    GE CARESCAPE Central Station audio alarms may be muted with unapproved keyboard

    GE Healthcare is recalling 10,445 CARESCAPE Central Station monitoring systems. If connected to an unapproved keyboard, audio alarms may be muted, potentially preventing users from receiving critical notifications.

    Product
    GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2022·2022-03-23

    RX CHOLANGIOGRAM KIT recalled due to sterile barrier breach

    Boston Scientific is recalling RX CHOLANGIOGRAM KIT due to a sterile barrier breach that compromises device sterility. Approximately 500 units distributed worldwide are affected.

    Product
    RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2022·2022-03-23

    Diagnostic ultrasound system ACUSON Juniper fails to save study clips

    The ACUSON Juniper ultrasound system's clip storage function fails when the disk is full, potentially delaying treatment during critical imaging procedures. Healthcare facilities using this system should contact Siemens for support.

    Product
    Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2022·2022-03-23

    Boston Scientific Medical Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 3,330 units of JAGTOME REVOLUTION RX devices due to a sterile barrier breach that compromises device sterility. The devices were distributed worldwide.

    Product
    JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2022·2022-03-23

    Lumbar Puncture Trays Recalled for Manometer Leaking and Assembly Defects

    Bard Peripheral Vascular Inc. is recalling 2,880 Lumbar Puncture Drug Free Trays due to defects in the manometer component involving leaking and mating issues that could affect device function.

    Product
    LUMBAR PUNCTURE DRUG FREE TRAY 22G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2022·2022-03-23

    Sterile barrier breach recalled in Boston Scientific HYDRATOME RX catheters

    Boston Scientific is recalling HYDRATOME RX catheters due to sterile barrier compromise. The 112 affected units worldwide may pose infection risk if used.

    Product
    HYDRATOME RX 49-20MM/260CM Material Number: M00583000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2022·2022-03-23

    Medical device sterile barrier breach compromises sterility in JAGTOME RX

    Boston Scientific is recalling 98 JAGTOME RX medical devices due to a sterile barrier breach. The affected units were distributed worldwide.

    Product
    JAGTOME RX 39-30-450-025 Material Number: M00573110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2022·2022-03-23

    Medical Device JAGTOME RX Recalled for Compromised Sterile Barrier

    Boston Scientific is recalling 3,578 units of the JAGTOME RX medical device because the sterile barrier is compromised, which can allow contamination. The affected units were distributed worldwide.

    Product
    JAGTOME RX 44-20-450-035 Material Number: M00573050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2022·2022-03-23

    Wright Medical ORTHOLOC Surgical Screw Recalled for Incorrect Component Packaging

    Wright Medical Technology's ORTHOLOC Non-Locking Screw was recalled due to a packaging error in lot #73967511638696, where locking screws were mistakenly packaged instead. The affected product was distributed to France.

    Product
    Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0777-2022·2022-03-23

    Boston Scientific JAGTOME RX Medical Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.

    Product
    JAGTOME RX 49-20-260-035 Material Number: M00573000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2022·2022-03-23

    LINQ II Insertable Cardiac Monitor Recalled for Moisture Ingress

    Medtronic is recalling 8 LINQ II Insertable Cardiac Monitors due to moisture ingress susceptibility that may cause loss of functionality. Affected devices were distributed in the US (NJ, NY, PA, VA) and Italy.

    Product
    LINQ II Insertable Cardiac Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2022·2022-03-23

    Boston Scientific JAGTOME RX medical device recalled for sterile barrier breach

    Boston Scientific has recalled 1,447 units of the JAGTOME RX 39-30-260-025 medical device due to a compromised sterile barrier that affects device sterility. The affected devices were distributed worldwide.

    Product
    JAGTOME RX 39-30-260-025 Material Number: M00573100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2022·2022-03-23

    DREAMTOME medical device recall: sterility compromised by barrier breach

    Fifteen Boston Scientific DREAMTOME medical devices are being recalled due to a sterile barrier breach that compromises device sterility. The affected lot number 27802363 requires appropriate action.

    Product
    DREAMTOME 49-20MM/450CM Material Number: M00584020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2022·2022-03-23

    Medical device sterile barrier breach in Boston Scientific HYDRATOME RX

    Boston Scientific is recalling HYDRATOME RX 49-30MM/260CM devices worldwide because sterile barriers are compromised. The manufacturing defect affects device sterility.

    Product
    HYDRATOME RX 49-30MM/260CM Material Number: M00583010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2022·2022-03-23

    Traverse Rail Carrier E-System components with defective short screws

    Hill-Rom Traverse Rail Carrier E-System components contain non-conforming screws that are too short to secure the rail properly. The screws could loosen over time, causing the rail system to fall and potentially injure caregivers or patients.

    Product
    (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2022·2022-03-23

    BioPlex 2200 Syphilis Calibrator Set Recall Due to Vaccine Interference and Reagent Stability Issues

    Bio-Rad Laboratories is recalling 724 BioPlex 2200 Syphilis Calibrator sets due to COVID-19 vaccine interference concerns and manufacturing problems with reagent stability. The recalled lots were distributed nationwide in the U.S. and internationally.

    Product
    BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2022·2022-03-23

    JAGTOME RX medical device recalled for sterile barrier breach

    Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.

    Product
    JAGTOME RX 39-20-450-025 Material Number: M00573090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0761-2022·2022-03-23

    Boston Scientific Hydratome RX Devices Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling Hydratome RX 44-30MM/260CM devices due to a sterile barrier breach that could compromise device sterility. The recall affects 3,371 units distributed worldwide.

    Product
    HYDRATOME RX 44-30MM/260CM Material Number: M00583050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2022·2022-03-23

    Adult Lumbar Puncture Drug Free Tray Recalled for Manometer Leaking

    Bard Peripheral Vascular Inc is recalling 1,260 Adult Lumbar Puncture Drug Free Trays due to manometer leaking and mating issues that could affect device function.

    Product
    ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
    Category
    Medical Device
    Distribution
    Distributed nationwide