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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12051–12075 of 27470

  • HighFDA (Devices)·Z-1139-2021·2021-03-03

    DeRoyal Open Heart Packs Recalled Due to Non-Sterile Sternum Saw Blades

    DeRoyal Industries is recalling 1,084 Open Heart Packs because the included sternum saw blades were not sterile, despite being part of a surgical procedure pack.

    Product
    Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1140-2021·2021-03-03

    DeRoyal Heart Pack Recall Due to Non-Sterile Sternum Saw Blades

    DeRoyal Industries is recalling Heart Packs containing non-sterile sternum saw blades. The affected surgical saw blades are marked with a green non-sterile sticker.

    Product
    Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1147-2021·2021-03-03

    Northgate Recalls ConMed Abdominal Insufflators Due to Incorrect Tubing Material

    Northgate Technologies is recalling 25 ConMed 50L abdominal insufflators because an internal tubing component was made with untested material.

    Product
    ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2021·2021-03-03

    Natus EDS 3 CSF External Drainage System Recalled for Pyrogen Test Failure

    Natus Manufacturing Limited is recalling 7 units of the EDS 3 CSF External Drainage System because the device failed to meet pyrogen test requirements for endotoxins.

    Product
    Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2021·2021-03-03

    Respironics Recalls 94 Philips Ventilator Batteries Due to Design Verification Issues

    Respironics is recalling 94 Philips V60 ventilator batteries because they were shipped without proper design verification. The recall covers distribution across multiple U.S. states.

    Product
    PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2021·2021-03-03

    Smiths Medical Recalls Bivona Cuffless FlexTend Tracheostomy Tubes Due to Packaging Error

    Smiths Medical is recalling specific lots of Bivona Cuffless FlexTend Tracheostomy Tubes because they may have been packaged with the wrong neck flange, posing a risk of patient injury.

    Product
    Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1142-2021·2021-03-03

    Recall of Parietex Hydrophilic Anatomical Mesh Due to Incorrect Side Labeling

    Covidien is recalling Parietex hydrophilic anatomical mesh where the package label indicates left-side use but contains a right-side device. This labeling error can lead to implant failure and hernia recurrence.

    Product
    Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2021·2021-03-03

    Northgate Recalls Steris CO2MPACT Endoscopic Insufflator Systems Due to Tubing Material Error

    Northgate Technologies is recalling 45 Steris CO2MPACT Endoscopic Insufflator systems because an internal tubing component was made with incorrect, untested material.

    Product
    Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2021·2021-03-03

    Ecolab Recalls Slush and Warmer Disc Drapes Due to Sterile Barrier Risk

    Ecolab is recalling specific lots of ORS-320 Slush + Warmer Disc Drapes because manufacturing slits may breach the sterile barrier, posing an infection risk to patients.

    Product
    Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1114-2021·2021-02-24

    Combat Medical Systems Recalls Fresh Whole Blood Donor Sets

    Combat Medical Systems is recalling 954 Fresh Whole Blood Donor Sets due to a potential bent or disconnected needle in the kit components.

    Product
    Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1112-2021·2021-02-24

    Combat Medical Systems Recalls Low Titer Type O FWB Transfusion Sets

    Combat Medical Systems, LLC is recalling 1021 units of Low Titer Type O FWB Transfusion Sets due to the potential for bent or disconnected needles in the components.

    Product
    Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2021·2021-02-24

    Baxter Gambro Hemodialysis Blood Set Recalled for Kinked Access Lines

    Baxter Healthcare is recalling Gambro Cartridge Low Volume Blood Transport Systems for hemodialysis due to reports of kinked access lines during treatment.

    Product
    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1109-2021·2021-02-24

    BD 10 ml Syringes Recalled for Potential Open Seals and Sterility Compromise

    Becton Dickinson is recalling 155,200 10 ml syringes because open packaging seals may compromise sterility. The product was distributed in the US and Canada.

    Product
    BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2021·2021-02-24

    Baxter Gambro Cartridge Single Needle Conversion Kit Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Single Needle Conversion Kits due to reports of kinked access lines during hemodialysis treatments.

    Product
    Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1113-2021·2021-02-24

    Combat Medical Systems Recalls Fresh Whole Blood Transfusion Sets

    Combat Medical Systems is recalling Fresh Whole Blood Transfusion Sets due to a potential for bent or disconnected needles in the kit components.

    Product
    Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2021·2021-02-24

    Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to reports of kinked access lines observed during treatment.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1126-2021·2021-02-24

    Confirm Biosciences Recalls Orient Gene COVID-19 Rapid Test Cassettes

    Confirm Biosciences is recalling Orient Gene COVID-19 Rapid Test Cassettes because they were distributed outside Emergency Use Authorization and not validated for fingerstick use.

    Product
    Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2021·2021-02-24

    Getinge CM320 Washer Disinfector Recalled for Hose Deformation Risk

    Getinge is recalling CM320 Series Washer Disinfectors because plastic inlet hose connections may deform or break, potentially causing water leaks and burns.

    Product
    Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2021·2021-02-24

    Biomet Recalls Mislabelled 25mm Shoulder Prosthesis Central Screws

    Biomet is recalling 49 units of 25mm central screws for shoulder prostheses because they were mislabeled as 25mm but are actually 40mm.

    Product
    Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2021·2021-02-24

    Baxter Recalls Gambro Hemodialysis Blood Sets Due to Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Low Weight-Low Volume Blood Transport Systems for hemodialysis because of complaints regarding kinked access lines observed during treatment.

    Product
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1129-2021·2021-02-24

    GE Healthcare Recalls Revolution CT Systems Due to Table Pinch Protector Issue

    GE Healthcare is recalling 96 Revolution CT systems because a damaged or missing table pinch protector may expose sharp screws, posing a laceration risk.

    Product
    System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2021·2021-02-24

    GE Healthcare Recalls Revolution CT Systems Due to Table Pinch Protector Defect

    GE Healthcare is recalling Revolution CT and Revolution CT ES systems because damaged or missing table pinch protectors may expose sharp screws, posing a laceration risk.

    Product
    System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2021·2021-02-24

    LumiraDx SARS-CoV-2 Antigen Test Strips Recalled for False Positives

    LumiraDx is recalling specific lots of SARS-CoV-2 antigen test strips due to potential false positive results that could lead to unnecessary treatment or quarantine.

    Product
    LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests.…
    Category
    Medical Device
    Distribution
    4 states