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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25501–25525 of 40233

  • HighFDA (Devices)·Z-0089-2018·2017-11-15

    Epimed Recalls TUOHY Epidural Needles Due to Potential Sterility Seal Issues

    Epimed International is recalling 263 units of TUOHY Epidural Needles because a partially incomplete seal could impact the product's sterility.

    Product
    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0086-2018·2017-11-15

    BioMerieux NucliSENS Lysis Buffer Recalled for Potential PCR Inhibition

    BioMerieux SA is recalling 911 units of NucliSENS Lysis Buffer because residual heme may inhibit PCR reactions, leading to uninterpretable test results.

    Product
    NucliSENS Lysis Buffer Extended lot for RES 76675
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0081-2018·2017-11-15

    Boston Scientific Recalls 11 Resonate X4 CRT-D Devices for Firmware Error

    Boston Scientific is recalling 11 Resonate X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE X4 CRT-D, Model G447, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0085-2018·2017-11-15

    Bioseal Custom Surgical Kits Recalled for Expired Iodine Prep Pads

    Bioseal Corporation is recalling custom surgical kits containing Aplicare Providone Iodine Prep Pads due to incorrect expiration dates.

    Product
    Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0084-2018·2017-11-15

    BD Vacutainer Blood Collection Tubes Recalled for Incorrect Labeling

    Becton Dickinson is recalling 90,000 blood collection tubes due to incorrect labeling at the case and shelf pack level.

    Product
    BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2018·2017-11-15

    Boston Scientific Recalls Four Momentum X4 CRT-D Devices for Firmware Error

    Boston Scientific is recalling four Momentum X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    MOMENTUM X4 CRT-D, Model G138, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0066-2018·2017-11-15

    Encore Medical Recalls Cobalt Bone Cement Due to Packaging Seal Loss

    Encore Medical, Lp is recalling 1,815 units of Cobalt MV with Gentamicin bone cement because the sterile Tyvek packaging seal was lost.

    Product
    Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0077-2018·2017-11-15

    Boston Scientific Recalls Five Resonate EL ICD VR Devices for Firmware Error

    Boston Scientific is recalling five Resonate EL ICD VR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE EL ICD VR, Model D432, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0064-2018·2017-11-15

    Biomet Cobalt HV Bone Cement Recalled for Packaging Seal Loss

    Encore Medical is recalling Biomet Cobalt HV Bone Cement because the sterile Tyvek packaging seal may be lost, potentially compromising sterility.

    Product
    Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0079-2018·2017-11-15

    Boston Scientific Recalls Four VIGILANT X4 CRT-D Devices for Firmware Error

    Boston Scientific is recalling four VIGILANT X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0071-2018·2017-11-15

    Aaren Scientific AERO IOL Injection System Recalled for Incorrect Storage Labeling

    Aaren Scientific Inc. is recalling 786 boxes of AERO IOL Injection Systems because the recommended storage temperature on the label is incorrect.

    Product
    AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0073-2018·2017-11-15

    Northgate Electrohydraulic Lithotripter Probe Recalled for Incorrect Labeling

    Northgate Technologies is recalling 186 electrohydraulic lithotripter probes due to incorrect reference numbers on labels, which could delay patient care.

    Product
    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0082-2018·2017-11-15

    Invivo Recalls Xper Flex Cardio PhysioMonitoring Systems Due to Communication Errors

    Invivo Corporation is recalling 529 Xper Flex Cardio PhysioMonitoring systems because of intermittent communication issues between the host system and the device.

    Product
    Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be…
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0088-2018·2017-11-15

    Epimed COUDE Blunt Nerve Block Needle Recall for Sterility Concerns

    Epimed International is recalling COUDE Blunt Nerve Block Needles due to a potential seal defect that may compromise sterility.

    Product
    COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0059-2018·2017-11-08

    Teleflex Percuvance Percutaneous Surgical System Recalled for Tool Tip Breakage

    Teleflex is recalling specific Percuvance surgical instruments because the tool tip jaws may break, causing fragments to fall off during use.

    Product
    Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0058-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SF NAV Catheters Due to Display Error

    Biosense Webster is recalling THERMOCOOL SF NAV catheters because a system alert may cause physicians to ablate in unintended areas.

    Product
    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0057-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to Navigation System Alert

    Biosense Webster is recalling 19 THERMOCOOL catheters because they trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0056-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SMARTTOUCH Navigation Catheters

    Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0052-2018·2017-11-08

    Bios THERMI250 Radiofrequency System Recalled for Unintended Energy Emission

    Bios S.r.l. is recalling 167 THERMI250 Radiofrequency Systems because they may continue to emit RF energy after the PAUSE button is pressed.

    Product
    THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0054-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to System Alert Error

    Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0062-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plate

    Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.

    Product
    CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to Magnetic Distortion Alert

    Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0060-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plates

    Smiths Medical is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.

    Product
    CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plate

    Smiths Medical is recalling CADD Medication Cassette Reservoirs that may have been manufactured with an incorrect pressure plate. The recall covers units distributed worldwide.

    Product
    CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
    Category
    Medical Device
    Distribution
    Distributed nationwide