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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25576–25600 of 40357

  • HighFDA (Devices)·Z-0083-2018·2017-11-15

    Teleflex Auto Endo5 Clip Applier Recalled for Clip Misalignment

    Teleflex Medical is recalling 13,710 units of the Auto Endo5 Automatic Hem-o-lok Clip Applier because clips may misalign, jam, or fall out of the device.

    Product
    WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0075-2018·2017-11-15

    Terumo BCT Recalls Harvest Graft Delivery Packs Due to Seal Defect

    Terumo BCT is recalling 525 Harvest Graft Delivery Packs because some lots may lack a seal on the inner pouch, potentially compromising sterility.

    Product
    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2018·2017-11-15

    Lima Delta Cup Beater Positioner Recalled for Potential Welding Defects

    Lima is recalling 20 Delta Cup Beater Positioner units in the US due to suboptimal welding that may reduce mechanical strength and cause breakage during use.

    Product
    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0076-2018·2017-11-15

    Sorin FlexFlow Venous Cannula Recalled for Sharpness Defect

    Sorin Group USA is recalling a specific lot of FlexFlow Venous Cannulas because they are sharper or pointier than expected.

    Product
    FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2018·2017-11-15

    Encore Medical Recalls Cobalt MV Bone Cement Due to Packaging Seal Loss

    Encore Medical is recalling 840 units of Cobalt MV Bone Cement because the sterile Tyvek packaging seal may be lost, potentially compromising sterility.

    Product
    Cobalt MV Bone Cement 40GM, REF 402438, 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
  • HighFDA (Devices)·Z-0078-2018·2017-11-15

    Boston Scientific Recalls 12 Resonate EL ICD Devices for Firmware Error

    Boston Scientific is recalling 12 Resonate EL ICD DR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE EL ICD DR, Model D433, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0087-2018·2017-11-15

    Epimed RX-2 COUDE Epidural Needle Recalled for Potential Sterility Seal Defect

    Epimed International is recalling 500 units of RX-2 COUDE Epidural Needles due to a potential incomplete seal that may impact sterility.

    Product
    RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0070-2018·2017-11-15

    Zimmer Biomet Recalls Custom Titanium Knee Implant Due to Nickel Content

    Zimmer Biomet is recalling a custom titanium knee implant because it contained a nickel-containing screw, posing a risk to a patient with a nickel allergy.

    Product
    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0067-2018·2017-11-15

    Encore Medical Recalls Cobalt Bone Cement Due to Packaging Seal Loss

    Encore Medical, Lp is recalling Cobalt HV with Gentamicin bone cement because the sterile Tyvek packaging may have lost its seal, potentially compromising sterility.

    Product
    Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, 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
  • 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