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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18376–18400 of 27682

  • HighFDA (Devices)·Z-1373-2018·2018-04-18

    TriMed Inc. Recalls Hex Drivers Due to Epoxy Color Band Migration

    TriMed Inc. is recalling 1,525 hex drivers because the epoxy color band may migrate down the shaft or onto sterilization trays after sterilization.

    Product
    Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1355-2018·2018-04-18

    Bard Infant Feeding Tube Recalled for Ineffective Connector Fusion

    C.R. Bard is recalling 23,400 infant feeding tubes because the tubing and connector may not be effectively fused.

    Product
    Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2018·2018-04-18

    Beckman Coulter AQUIOS CL Flow Cytometer System Recalled for Sample ID Errors

    Beckman Coulter is recalling 288 AQUIOS CL Flow Cytometer Systems because the single tube loader may process the same sample with two different IDs, potentially causing erroneous results.

    Product
    AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2018·2018-04-18

    Arrow International Recalls Certain Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits because they may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1319-2018·2018-04-18

    Hill-Rom Progressa Bed Recall Due to Brake Component Failure Risk

    Hill-Rom is recalling 2,117 Progressa adjustable hospital beds because a braking system component may break, causing unwanted bed movement and potential injury.

    Product
    Progressa Bed - AC-powered adjustable hospital bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2018·2018-04-18

    Arrow International Recalls Arrowg+ard Blue PSI Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of Arrowg+ard Blue PSI Kits because the catheters may not be completely sealed, preventing a guarantee of sterility.

    Product
    Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1364-2018·2018-04-18

    Orthofix Recalls Connector System Set Screws Due to Size Discrepancies

    Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may cause the driver to wedge or strip the screw.

    Product
    ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1357-2018·2018-04-18

    Bard Premature Infant Feeding Tubes Recalled for Ineffective Fusion

    C.R. Bard is recalling specific lots of Bard Premature Infant Feeding Tubes because the tubing and ENFit connector may not be effectively fused.

    Product
    Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2018·2018-04-18

    Arrow International Recalls Certain Central Venous Catheterization Kits

    Arrow International is recalling specific lots of central venous and vessel catheterization kits because the seals may be incomplete, potentially compromising sterility.

    Product
    (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1327-2018·2018-04-18

    Arrow PICC Kit Recall Due to Potential Sterility Seal Failure

    Arrow International is recalling specific lots of ARROW PICC Kits because the seals may not be completely closed, meaning the product's sterility cannot be guaranteed.

    Product
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1336-2018·2018-04-18

    Arrow Hemodialysis Catheter Kits Recalled for Sterility Concerns

    Arrow International is recalling specific lots of hemodialysis catheterization kits because they may not be completely sealed, potentially compromising sterility.

    Product
    ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1363-2018·2018-04-18

    Orthofix Recalls Connector System Set Screws Due to Size Discrepancies

    Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may prevent proper driver fit or cause stripping.

    Product
    ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1371-2018·2018-04-18

    Hamilton-C2 Ventilator Units Recalled Due to Battery Fuel Gauge Inaccuracy

    Hamilton Medical AG is recalling 739 Hamilton-C2 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.

    Product
    Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1360-2018·2018-04-18

    Zimmer GmbH Recalls Normed Charcot Osteotome Chisels for Disinfection Gap

    Zimmer GmbH is recalling Normed Charcot Osteotome Chisels because a gap between the handle and metal chisel may prevent proper disinfection or sterilization between uses.

    Product
    Normed Charcot Osteotome Chisel (Various sizes)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1366-2018·2018-04-18

    Beckman Coulter iQ200 Urine Analyzer Recall for Barcode Reading Failures

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may fail to read dilution barcodes, causing erroneous results that could delay treatment.

    Product
    iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2018·2018-04-18

    Beckman Coulter iQ200 Urine Analyzer Recall for Under-Reporting Issue

    Beckman Coulter is recalling the iQ200 Series Urine Microscopy Analyzer because it may under-report casts when certain measurement settings are used. The issue could affect test results during initial setup or after settings are changed.

    Product
    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1354-2018·2018-04-18

    Bard Premature Infant Feeding Tube Recalled for Ineffective Fusion

    C.R. Bard is recalling 42,200 units of Bard Premature Infant Feeding Tubes due to potentially ineffective fusion between the tubing and the ENFit connector.

    Product
    Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2018·2018-04-11

    GE Healthcare Recalls Monica Novii Wireless Patch System Due to Signal Swap Risk

    GE Healthcare is recalling 1,742 units of the Monica Novii Wireless Patch System because incorrectly reconnected cables may cause fetal and maternal heart rate signals to be displayed swapped.

    Product
    Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2018·2018-04-11

    Fresenius K2 Hemodialysis Machines Recalled for SLED Program Software Defect

    Fresenius Medical Care is recalling 127 K2 Hemodialysis Machines because a software defect may allow the ultrafiltration pump to run at unsafe rates during SLED treatments.

    Product
    2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1280-2018·2018-04-11

    Baxter Recalls Prismaflex Control Units Due to Software and Usage Issues

    Baxter Healthcare is recalling 3,440 Prismaflex Control Units worldwide due to reports of operators failing to follow safe unloading instructions and software errors in specific versions.

    Product
    Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2018·2018-04-11

    C.R. Bard Recalls HydroSil Gripper Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling specific lots of HydroSil Gripper Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.

    Product
    HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2018·2018-04-11

    DePuy Spine Recalls Confidence Plus Kit Spinal Cement System Lots

    DePuy Spine is recalling specific lots of the Confidence Plus Kit Spinal Cement System because they may contain incorrect amounts of contrast medium, making the product difficult or impossible to visualize on x-ray.

    Product
    Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1308-2018·2018-04-11

    C.R. Bard Recalls Magic 3 Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling Magic 3 Intermittent Catheters because some units were caught in the sterile barrier seal or cut.

    Product
    Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2018·2018-04-11

    Seiler Alpha Air 6 ENT Microscope Recalled for Tipping Hazard

    Seiler Instruments is recalling Alpha Air 6 ENT Microscopes because they may tip over if attachments are extended and the device is moved improperly.

    Product
    Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
    Category
    Medical Device
    Distribution
    8 states