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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3326–3350 of 5038

  • SevereFDA (Devices)·Z-2226-2018·2018-06-20

    Seaberg SAM XT-M Tourniquet Recalled for Potential Buckle Failure

    The Seaberg Company is recalling SAM XT-M tourniquets because internal testing found stitches securing the buckle could fail, posing a risk of serious injury or death.

    Product
    Part #: SAM XT-M, Model: Tactical Black or Military
    Category
    Medical Device
    Distribution
    23 states
  • SevereFDA (Devices)·Z-2205-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 2 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M132324
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2222-2018·2018-06-20

    BioFlo PICC Nursing Kit Recalled for Unsafe Bacterial Endotoxin Levels

    Angiodynamics Inc. is recalling BioFlo PICC Nursing Kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2221-2018·2018-06-20

    Angiodynamics Recalls BioFlo PICC Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2214-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 104 boxes of RS 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M183481
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2174-2018·2018-06-20

    Philips Brilliance 64 CT System Recalled for Patient Support Head Holder Hazard

    Philips is recalling three Brilliance 64 CT systems because the patient support head holder could contact the back ISO shelter wall, posing a risk of serious injury.

    Product
    Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2118-2018·2018-06-13

    Orthofix Recalls Rival Reduce Kit Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling 50 units of Rival Reduce Kit Plates because locking screws failed to properly engage the plates during surgery.

    Product
    Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2132-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture Plating and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2121-2018·2018-06-13

    Orthofix Recalls Non-Locking Screws for Improper Plate Engagement

    Orthofix, Inc. is voluntarily recalling specific non-locking screws used in fracture plating systems because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM X 10MM (002-D-27010); c) D 2.7MM X 12MM (002-D-27012); d) D 2.7MM X 14MM (002-D-27014); e) D 2.7MM X 16MM (002-D-27016); f
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2125-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling specific Rival Reduce Fracture Plating and Rival View Plating System box plates because locking screws failed to properly engage during surgery.

    Product
    Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2135-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture and View Plating Systems because locking screws failed to engage plates during surgery.

    Product
    Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2131-2018·2018-06-13

    Orthofix Recalls MTP Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling specific MTP plates because locking screws failed to properly engage during surgery.

    Product
    MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2130-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2134-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2126-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2122-2018·2018-06-13

    Orthofix Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-2
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2035-2018·2018-06-06

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Charging Failure

    Philips is recalling five HeartStart MRx monitor/defibrillators because a faulty circuit board may prevent charging, potentially delaying life-saving therapy.

    Product
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2041-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1928-2018·2018-06-06

    Maquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps

    Maquet Datascope is recalling CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps because fluid ingress can damage electronic circuit boards, preventing therapy initiation or continuation.

    Product
    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2036-2018·2018-06-06

    Recall of Sterile Powdered Surgical Gloves Due to Banned Powder Content

    WRP Asia Pacific Sdn Bhd is recalling 201,000 pairs of AmerisourceBergen sterile surgical gloves because some left-handed gloves contain powder, which is banned in the U.S.

    Product
    AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2048-2018·2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal therma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2039-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b. Product Code LXMC-14; c. Product Code LXMC-15; d. Product Code LXMC-16; e. Product Code LXMC-17; Laparoscopic, fu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2038-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device discontinuous or open.

    Product
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1952-2018·2018-06-06

    Gyrus ACMI Reusable Active Cord Recalled for Fire Hazard

    Gyrus Acmi is recalling 6,447 reusable active cords for electrosurgical generators due to a potential risk of sparking and causing a fire.

    Product
    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1901-2018·2018-05-30

    LivaNova Recalls Sorin Stockert Heater-Cooler Systems Due to Suspected Microbial Contamination

    LivaNova USA is recalling 2,408 Sorin Stockert Heater-Cooler System 3T units because they are suspected of microbial contamination and may contain visible biofilm.

    Product
    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
    Category
    Medical Device
    Distribution
    44 states