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.

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22401–22425 of 40175

  • HighFDA (Devices)·Z-2764-2018·2018-09-26

    Degania Foley Catheters Recalled for Defective Temperature Sensors

    Degania Silicone is recalling 47,520 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than actual.

    Product
    Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2018·2018-09-26

    Degania Temperature Sensor Catheters Recalled for Defective Sensors

    Degania Silicone is recalling 16,350 temperature sensor catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3183-2018·2018-09-26

    Med-Mizer Recalls PR1000 Pivot Rehab Beds Due to Cable Pinching Risk

    Med-Mizer is recalling 230 PR1000 Pivot Rehab Beds because wires may become pinched during extreme left pivoting, requiring patient transfer until repaired.

    Product
    PR1000 Pivot Rehab Bed AC powered adjustable bed.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-2759-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone is recalling 1,028 temperature sensor catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3181-2018·2018-09-26

    Stryker Recalls IsoFlex LAL Support Surfaces Due to Fire Barrier Defect

    Stryker is recalling 243 IsoFlex LAL support surfaces because they were assembled with a non-conforming fire barrier. The units were distributed in five US states.

    Product
    IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 475 Temperature Sensor Foley Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3203-2018·2018-09-26

    Coviden Recalls Defective Temperature Sensing Foley Catheters

    Coviden is recalling specific sterile Foley catheter trays because the temperature sensors may display lower body temperature readings than the patient's actual temperature.

    Product
    400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-2770-2018·2018-09-26

    Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors

    Degania Silicone is recalling 250 Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 14,326 Thermistor Foley catheters because defective sensors may display inaccurate, lower body temperature readings.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2761-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone is recalling 16,133 temperature sensor catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2018·2018-09-26

    Degania Foley Catheters Recalled Due to Defective Temperature Sensors

    Degania Silicone is recalling Foley catheters with temperature sensors because defective units may display lower body temperatures than actual.

    Product
    Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3201-2018·2018-09-26

    Medtronic Recalls Contour Plus Link 2.4 Meters with Incorrect Units

    Medtronic is recalling two Contour Plus Link 2.4 meters distributed in Slovakia that display glucose in mg/dL instead of mmol/L.

    Product
    Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3200-2018·2018-09-26

    Arrow International Recalls PICC Kits Due to Incorrect Catheter Type

    Arrow International is recalling 5.5 Fr x 5.5 Fr x 40 cm double-lumen PICC Kits because they may contain the wrong catheter type, potentially delaying treatment.

    Product
    5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-3187-2018·2018-09-26

    Tecan Freedom EV0-2 Software Recall for Sample Tracking Issues

    Tecan US, Inc. is recalling Freedom EV0-2 devices with EVOware Sample Tracking Add-On V1.0 or higher due to a software issue that can impact sample identification and traceability.

    Product
    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3198-2018·2018-09-26

    Biocare Medical Recalls URO-3 Triple Stain Kits Due to Component Mislabeling

    Biocare Medical is recalling 11 URO-3 Triple Stain kits because two components were mislabeled, causing incorrect staining patterns in laboratory tests.

    Product
    URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3190-2018·2018-09-26

    Siemens ARTIS Pheno X-Ray System Recalled for Temperature Control Defect

    Siemens is recalling 429 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool below its designed operating range.

    Product
    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3199-2018·2018-09-26

    Arrow International Recalls PICC Kits Due to Incorrect Catheter Inclusion

    Arrow International is recalling specific PICC kits because they may contain the wrong catheter type, potentially delaying patient treatment.

    Product
    4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-3179-2018·2018-09-26

    bioMerieux Recalls VITEK 2 AST-P640 Cards Due to Gentamicin Error

    bioMerieux is recalling VITEK 2 AST-P640 cards because some lots contain insufficient gentamicin, potentially affecting high-level resistance test results.

    Product
    VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3182-2018·2018-09-26

    Mako Surgical Recalls RIO Standard System Components for Connection Errors

    Mako Surgical Corporation is recalling 910 units of the Makoplasty RIO Standard System and Ethernet to Fiber Optic Converter due to communication-connection errors.

    Product
    Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3197-2018·2018-09-26

    Arrow Bipolar Electrode Catheter Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 7 units of a specific bipolar electrode catheter lot because they are labeled with an incorrect expiration date.

    Product
    ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
    Category
    Medical Device
    Distribution
    1 state