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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9201–9225 of 27441

  • HighFDA (Devices)·Z-0182-2023·2022-11-16

    Sedecal Soltus Battery Mobile X-Ray Systems Recalled for Unintended Movement

    Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.

    Product
    Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0197-2023·2022-11-16

    Orthopedic Surgical Blade Recall Due to Incorrect Configuration

    Beaver Arthro-Lok surgical blades may have been configured to curve right instead of left. If used during surgery, the incorrect curve could cause unintended tissue damage.

    Product
    Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0222-2023·2022-11-16

    X-Guide X-Mark Probe Tool Recall: Missing Weld Creates Aspiration Risk

    X-NAV Technologies is recalling the X-Guide X-Mark Probe Tool because a critical weld may be missing, potentially allowing the probe tip to detach and fall into a patient's mouth during use, creating a risk of aspiration or swallowing.

    Product
    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Contraindicated for Infants and Neonates

    Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.

    Product
    Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Restricted for Infants

    Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.

    Product
    Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2023·2022-11-16

    Scalpel and StatLock in HydroPICC kits expire before label indicates

    Access Vascular recalls 79 HydroPICC catheter kits because included scalpel and StatLock components have earlier expiration dates than stated on the package.

    Product
    Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0190-2023·2022-11-16

    Cardinal Health Insulated Gel Pack Reusable Medium Contraindicated for Infant Use

    Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised with a caution statement.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2023·2022-11-16

    Sterile Medical Extension Sets Distributed Without Expiration Dates

    Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.

    Product
    Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessor
    Category
    Medical Device
    Distribution
    11 states
  • CriticalFDA (Devices)·Z-0153-2023·2022-11-09

    CritiCool Thermoregulation Device Recalled Due to Pump Failure

    The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.

    Product
    CritiCool, thermoregulation device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0144-2023·2022-11-09

    Hillrom WatchCare Incontinence System Recalled for Radio Frequency Interference

    Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System (63 units in US) because radio frequency emissions from the device may interfere with other medical equipment including infusion pumps and insulin pumps.

    Product
    Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0141-2023·2022-11-09

    Hillrom Centrella Hospital Bed Radio Frequency Emissions May Interfere with Medical Devices

    Hillrom Centrella Hospital Beds with WatchCare systems may emit radio frequency signals that interfere with other medical devices. Approximately 6,407 units are affected and distributed in the US.

    Product
    Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7900B100244, P7900B100256, P7900B100257, P7900B100259, P7900B100264, P7900B100268, P7900B100269, P7900B
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0143-2023·2022-11-09

    Hillrom WatchCare Incontinence System Recalled for Radio Frequency Interference

    Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System for Progressa Bed due to potential radio frequency emissions that may interfere with other medical devices including telemetry monitors and infusion pumps.

    Product
    Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0142-2023·2022-11-09

    Hillrom WatchCare Incontinence System recalled for radio frequency interference risk

    Baxter Healthcare is recalling the Hillrom WatchCare Incontinence Management System due to radio frequency emissions that may interfere with other critical medical devices including insulin pumps and fetal monitors.

    Product
    Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0145-2023·2022-11-09

    Hillrom WatchCare Incontinence System Recalled for Radio Frequency Emissions

    Baxter Healthcare is recalling 129 units of the Hillrom WatchCare incontinence management system due to radio frequency emissions that may interfere with other hospital medical devices such as telemetry units, fetal monitors, and insulin pumps.

    Product
    Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0146-2023·2022-11-09

    Fogarty Arterial Embolectomy Catheters Recalled for Latex Deterioration

    Edwards Lifesciences is recalling 715,620 Fogarty Arterial Embolectomy Catheters due to confirmed latex deterioration in the pouch packaging. The material degradation could affect device performance during use.

    Product
    Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2023·2022-11-09

    BD Trucount Tubes Recalled Due to Partial Label Detachment Causing Operational Failures

    Becton Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together in pouches or fail when used with automated loaders. No illnesses have been reported.

    Product
    BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the B
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0164-2023·2022-11-09

    Medline Dental Pack Recall Due to Breather Pouch Seal Defect

    Medline is recalling Dental Pack surgical kits (Lot 22DBE139) because breather pouches have openings in their seals that could compromise sterility. Affected units were distributed to healthcare facilities in eight US states.

    Product
    MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2023·2022-11-09

    Boston Scientific EMBLEM S-ICD Subcutaneous Defibrillators Software Defect Causes Battery Display Error

    Boston Scientific is recalling 7 EMBLEM S-ICD Model A209 subcutaneous defibrillators due to a software defect that displays inaccurate battery capacity information. Patients may not realize when their device's battery requires replacement.

    Product
    EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2023·2022-11-09

    Bausch + Lomb Ophthalmic Surgical Kits Recalled for Sterile Packaging Defect

    Medline Industries is recalling 800 Bausch + Lomb Basic Ophthalmic surgical kits (Lot 22DBN365) for defective breather pouch seals. Opened seals in the packaging compromise the sterile conditions required for surgical procedures.

    Product
    BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2023·2022-11-09

    Transcutaneous monitor attachment rings recalled for weak skin adhesion

    SenTec AG voluntarily recalled 17,208 units of transcutaneous CO2/O2 monitor attachment rings due to weak skin adhesion. The devices, used in noninvasive patient monitoring, were distributed nationwide.

    Product
    sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2023·2022-11-09

    Operating Room Table With Defective Adhesive May Lose Mechanical Integrity

    Baxter Healthcare is recalling Allen Advance operating room tables because adhesive securing fasteners may not cure properly, potentially compromising mechanical integrity.

    Product
    Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0179-2023·2022-11-09

    Allen Life Assist Beach Chair Adhesive Cure Failure Recall

    Baxter Healthcare is recalling the Allen Life Assist Beach Chair due to adhesive on fasteners that may not cure correctly, potentially compromising the device's mechanical integrity during surgical procedures.

    Product
    Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0161-2023·2022-11-09

    Surgical Cataract Packs with Compromised Breather Pouch Seals Recalled

    Medline recalls 708 Bausch + Lomb cataract surgical packs due to breather pouch seal defects that could compromise sterility of surgical instruments.

    Product
    BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2023·2022-11-09

    Allen Spine Positioner Components Recalled for Adhesive Curing Defect

    Baxter Healthcare is recalling Allen Standard Starburst spine positioning components due to adhesive that may not cure correctly, potentially compromising mechanical holding force in surgical head positioning devices.

    Product
    Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0163-2023·2022-11-09

    Medline LINQ Surgical Trays Recalled for Compromised Pouch Seals

    Medline has recalled LINQ TRAY surgical kits with breather pouch seal openings that could compromise sterility. The recall affects 40 kits distributed nationwide; no injuries have been reported.

    Product
    MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide