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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16426–16450 of 39988

  • HighFDA (Devices)·Z-2799-2020·2020-08-19

    United Imaging Recalls uEXPLORER PET/CT System for Potential Sharp Edges

    Shanghai United Imaging Healthcare is recalling one uEXPLORER PET/CT Diagnostic Imaging System in Texas due to potential sharp edges and image data issues.

    Product
    uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2800-2020·2020-08-19

    United Imaging Recalls uMI 550 PET/CT Systems Due to Imaging and Safety Defects

    Shanghai United Imaging Healthcare is recalling four uMI 550 PET/CT systems due to defects that may cause image artifacts, scanning interruptions, or sharp edges.

    Product
    uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 calcaneus plates because the contract manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2020·2020-08-19

    Ortho Clinical Diagnostics Recalls VITROS Anti-SARS-CoV-2 IgG Reagent Packs

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs because swapped reagent bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2020·2020-08-19

    Luminex Verigene Processor SP Recalled for Potential False Negative Results

    Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results in blood culture tests.

    Product
    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2793-2020·2020-08-19

    Brainlab Kick Navigation Station Recalled for Incorrect Calibration

    Brainlab AG is recalling 9 Kick navigation stations due to incorrect manufacturer calibration. The units were distributed in the US and internationally.

    Product
    BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2804-2020·2020-08-19

    Arrow International Recalls NextStep Retrograde Replacement Hub Set Due to Labeling Error

    Arrow International is recalling NextStep Retrograde Replacement Hub Sets because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2789-2020·2020-08-19

    HF Acquisition Recalls Emergency Medical Kits with Missing Narcan Dose

    HF Acquisition Co., LLC is recalling 95 STAT KIT Model SM30 emergency medical kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2782-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because they were manufactured with a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2784-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 calcaneus plates because the manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2803-2020·2020-08-19

    Arrow TheraCath Epidural Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling TheraCath Epidural Catheters because the lidstock displays an incorrect expiration date, potentially leading to the use of expired devices.

    Product
    Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2786-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because the manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2802-2020·2020-08-19

    Arrow International Recalls Cannon II Plus Replacement Hub Sets for Labeling Error

    Arrow International Inc is recalling Cannon II Plus Replacement Hub Sets because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2788-2020·2020-08-19

    HealthFirst Emergency Medical Kit Recalled for Missing Narcan Dose

    HF Acquisition Co. is recalling HealthFirst Emergency Medical Kits because they contain one dose of Narcan nasal spray instead of two.

    Product
    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number…
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2791-2020·2020-08-19

    HF Acquisition Recalls STAT KIT Emergency Medical Kits with Missing Narcan Dose

    HF Acquisition Co., LLC is recalling STAT KIT Model 550AI Emergency Medical Kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2779-2020·2020-08-19

    HealthFirst STAT KIT Z-1000 Emergency Medical Kits Recalled for Missing Component

    HF Acquisition Co. LLC is recalling two STAT KIT Z-1000 emergency medical kits because they are missing a hand suction pump component.

    Product
    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2792-2020·2020-08-19

    Brainlab Curve Navigation Stations Recalled for Incorrect Manufacturer Calibration

    Brainlab AG is recalling 18 Curve navigation stations due to incorrect manufacturer calibration. The devices were distributed in the US and internationally.

    Product
    BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2790-2020·2020-08-19

    HF Acquisition Recalls STAT KIT 550 Emergency Medical Kits

    HF Acquisition Co., LLC is recalling 155 STAT KIT Model 550 Emergency Medical Kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2787-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 Calcaneus Plates, Extensile, Large, Right (Catalog Number CPF 203) because the contract manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2798-2020·2020-08-19

    FDA Recalls Barricaid Annual Closure Devices Due to Labeling Error

    Intrinsic Therapeutics is recalling 110 units of Barricaid Annual Closure Devices because the inner container labels display the wrong catalog number.

    Product
    Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2796-2020·2020-08-19

    Wright Medical Hardware Removal Kit Recalled for Missing Drivers

    Wright Medical Technology is recalling 66 hardware removal kits because they lack the specific drivers needed to remove Dart-Fire 2.5 and 3.0mm Headless screws.

    Product
    Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2777-2020·2020-08-19

    Smith & Nephew Recalls Misidentified PeriLoc Targeter Handle

    Smith & Nephew is recalling 3 units of a PeriLoc Targeter handle that was incorrectly marked as a left-hand part.

    Product
    PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2801-2020·2020-08-19

    Arrow Single Shot Epidural Anesthesia Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling specific lots of Single Shot Epidural Anesthesia Kits because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2783-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because they were manufactured with a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide