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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3451–3475 of 5111

  • SevereFDA (Devices)·Z-1365-2018·2018-04-18

    Fresenius Liberty Select Cycler Recalled for Software Overfill Risk

    Fresenius Medical Care is recalling Liberty Select Cyclers due to a software issue that may cause overfill, posing a risk of serious injury or death.

    Product
    Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1351-2018·2018-04-18

    W & H DentalWerk Recalls S-N1 and S-N2 Foot Controls

    W & H DentalWerk is recalling S-N1 and S-N2 foot controls because they may fail to stop the motor, posing a risk of serious patient injury.

    Product
    Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1243-2018·2018-04-04

    Stryker Recalls Break-Away Femoral Nozzles Due to Sterility Concerns

    Stryker is recalling 384 Break-Away Femoral Nozzles because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.

    Product
    Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1260-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 93 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1244-2018·2018-04-04

    Stryker Recalls 180-Gram Cement Cartridges Due to Sterility Assurance Issues

    Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.

    Product
    180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1247-2018·2018-04-04

    Stryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns

    Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1262-2018·2018-04-04

    Allen Medical Systems Recalls F-T3SYSTEM Surgical Table Accessories

    Allen Medical Systems is recalling 83 F-T3SYSTEM surgical table accessories because rail section clamps may fail during use, posing a risk of critical harm to patients.

    Product
    F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1253-2018·2018-04-04

    Stryker Recalls iVAS System Kits Due to Sterility Assurance Issues

    Stryker is recalling 51 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.

    Product
    10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1236-2018·2018-04-04

    Zimmer Biomet Recalls Phoenix Nail System Inserter Connectors Due to Fracturing

    Zimmer Biomet is recalling specific lots of Phoenix Nail System 3.5mm Inserter Connectors because they have fractured and remained in the device implant.

    Product
    Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1175-2018·2018-04-04

    ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1275-2018·2018-04-04

    Ray Station Software Recalled for Potential Incorrect Radiation Treatment Volume

    RaySearch Laboratories is recalling Ray Station 4.9 through 7 software due to a defect that may result in incorrect treatment volumes being delivered to patients.

    Product
    Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1249-2018·2018-04-04

    Stryker Spinal Orthopedic PCD Kit Recalled for Sterility Assurance Issues

    Stryker is recalling 12 units of a spinal orthopedic PCD kit because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.

    Product
    PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1119-2018·2018-03-28

    MedComp Repair Kit Recalled for Potential Connection Failures

    Medical Components, Inc. is recalling 5 MedComp Repair Kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1075-2018·2018-03-28

    Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope Recalled for Misdirected Energy

    Iridex Corporation is recalling the TruFocus LIO Premiere Laser Indirect Ophthalmoscope because laser energy was not directed as intended, causing focal cataracts and iris burns.

    Product
    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1100-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1133-2018·2018-03-28

    Boston Scientific Recalls SpyScope DS Biliary Catheters Due to Sleeve Defect

    Boston Scientific is recalling 5,026 units of SpyScope DS Access and Delivery diagnostic biliary catheters because a sleeve may protrude, causing tissue damage or bleeding.

    Product
    SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1123-2018·2018-03-28

    MedComp Recalls 12F Modified Tesio Catheter Sets Due to Connection Failures

    Medical Components, Inc. is recalling 40 kits of 12F Modified Tesio Catheter Sets because connection failures could cause blood loss or air emboli.

    Product
    12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1124-2018·2018-03-28

    MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.

    Product
    12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1122-2018·2018-03-28

    MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 385 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.

    Product
    12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1127-2018·2018-03-28

    MedComp Repair Kit Recalled for Potential Connection Failures and Blood Loss Risk

    Medical Components, Inc. is recalling 1,575 MedComp Repair Kits due to potential connection failures that could lead to blood loss or air emboli.

    Product
    REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1104-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling certain Malecot Nephrostomy Catheters because they are breaking at the mid-shaft bond during use.

    Product
    Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1125-2018·2018-03-28

    MedComp Two Part Adapter Recall for Potential Connection Failures

    Medical Components, Inc. is recalling 35 MedComp Two Part Adapter kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1118-2018·2018-03-28

    MedComp Recalls Catheter Repair Kits Due to Connection Failure Risk

    Medical Components, Inc. is recalling 93 Catheter Repair Kits because potential connection failures could lead to blood loss or air emboli.

    Product
    CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1073-2018·2018-03-21

    Smiths Medical Recalls Misassembled Port-A-Cath Implantable Port Kits

    Smiths Medical ASD Inc. is recalling certain Port-A-Cath II kits that may contain incorrect introducer sizes or locking collars due to misassembly.

    Product
    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0981-2018·2018-03-21

    Alden Optical Recalls NovaKone Daily Wear Soft Contact Lenses

    Alden Optical is recalling NovaKone Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the US and Canada.

    Product
    NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with
    Category
    Medical Device
    Distribution
    Distributed nationwide