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 the agency’s own highest classification or reported deaths or serious injuries, 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.

Filters

Agency

Category

Minimum severity

Clear filters

25351–25375 of 40233

  • ModerateFDA (Devices)·Z-0221-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete packaging seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0218-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheath Due to Incomplete Seal

    Terumo Medical Corp is recalling a specific lot of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0225-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0220-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0253-2018·2017-12-20

    ConMed Recalls Nonabsorbable Suture Anchor System Due to Manufacturing Error

    ConMed Corporation is recalling 56 units of a nonabsorbable suture anchor system because they were manufactured with the incorrect anchor outer body.

    Product
    Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0214-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0223-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0216-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0051-2018·2017-12-20

    United Nuclear Scientific Recalls Three High Power Handheld Lasers

    United Nuclear Scientific Supplies, LLC is recalling three high power handheld laser products for failing to comply with laser class limitations.

    Product
    United Nuclear Scientific High Power Handheld Lasers. Laser products
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0217-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0237-2018·2017-12-20

    Beckman Coulter UniCel DxH600 Hematology Analyzer Recall for Sample Aspiration Issue

    Beckman Coulter is recalling the UniCel DxH600 automated hematology analyzer because a shield may interfere with sample aspiration.

    Product
    UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0233-2018·2017-12-20

    Dukal Blue Burn Sheets Recalled Due to Shredded Product in Cartons

    Dukal Corp. is recalling sterile Blue Burn Sheets because intact cartons were found to contain shredded sheets, compromising the sterile barrier.

    Product
    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0215-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0236-2018·2017-12-20

    Beckman Coulter UniCel DxH800 Automated Hematology Analyzer Recall

    Beckman Coulter is recalling 15 UniCel DxH800 automated hematology analyzers because the Single-Tube Station shield may interfere with sample aspiration.

    Product
    UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0205-2018·2017-12-13

    FDA Recalls Unapproved Compressible Limb Therapy Systems Due to Incorrect Air Compression

    Won Industry Co. is recalling three unapproved Compressible Limb Therapy Systems because they have incorrect air compression level setups. The devices were distributed in Maryland, Texas, and Mexico.

    Product
    Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2018·2017-12-13

    Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Listeria Contamination

    Becton Dickinson is recalling Trypticase Soy Agar with 5% Sheep Blood plates because they are contaminated with Listeria monocytogenes. The affected lots are distributed worldwide.

    Product
    TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0210-2018·2017-12-13

    Biosense Webster Recalls SMARTABLATE RF System Generator Units

    Biosense Webster is recalling 185 SMARTABLATE RF System Generators because they may inadvertently deliver RF energy if the foot pedal is placed near Stereotaxis magnets.

    Product
    SMARTABLATE RF System Generator
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0207-2018·2017-12-13

    BD Precision Glide Needles Recalled for Hub Damage and Leakage

    Becton Dickinson is recalling 2,598,000 BD Precision Glide Needles due to hub damage that can cause breakage or leakage during use.

    Product
    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2018·2017-12-13

    Pro-Med Instruments Recalls DORO Sterile Disposable Skull Pins Due to Breakage

    Pro-Med Instruments is recalling DORO Sterile Disposable Skull Pins because two instances of pin tip breakage were reported during surgery.

    Product
    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2018·2017-12-13

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Bug

    Roche Diabetes Care is recalling the Accu-Chek Connect app because a bug in the Bolus Advisor feature may prevent correction bolus advice from being available for recent glucose readings.

    Product
    Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2018·2017-12-13

    GE CARESCAPE Patient Data Module Recalled for Missing Apnea Alarms

    GE Medical Systems is recalling CARESCAPE Patient Data Module software because it fails to generate visual or audible alarms for impedance respiration apnea events.

    Product
    CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0195-2018·2017-12-13

    ICU Medical Recalls MedNet Medication Management Suite Software

    ICU Medical Inc is recalling MedNet 6.1 and 6.21 software because it may alter piggyback medication settings without user notice.

    Product
    ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide