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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36351–36375 of 40449

  • SevereFDA (Devices)·Z-0955-2014·2014-03-05

    Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1053-2014·2014-03-05

    Medline Recalls Sterile Sample Cath Lab Packs Due to Coating Defect

    Medline Industries is recalling 10 units of Sterile Sample Cath Lab Packs because a guidewire component has a potential for its coating to flake off.

    Product
    STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1089-2014·2014-03-05

    Orthofix Azure Anterior Cervical Plate System Recall for Fracture Risk

    Orthofix is recalling Azure Anterior Cervical Plate Systems because the locking mechanism may fracture during or after implantation.

    Product
    Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1072-2014·2014-03-05

    GE Healthcare Recalls Giraffe and Panda Infant Warmers Due to Reversed Fittings

    GE Healthcare is recalling Giraffe and Panda iRes Infant Warmers because oxygen and air wall inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1055-2014·2014-03-05

    Medline Recalls Angiography Drape Packs Due to Guidewire Coating Defect

    Medline Industries is recalling 50 units of CATH ANGIOGRAPHY DRAPE PACKS because a guidewire inside the kits has a potential for its coating to flake off.

    Product
    CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1056-2014·2014-03-05

    Medline Recalls Surgical Kits with Flaking Guidewire Coating

    Medline Industries is recalling 112 surgical kits containing guidewires with a potential for coating to flake off.

    Product
    CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1047-2014·2014-03-05

    Medline Recalls Angio Pack #2 Surgical Kits Due to Coating Defect

    Medline Industries is recalling 768 units of Angio Pack #2 surgical kits because a guidewire component has a potential for its coating to flake off.

    Product
    ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0953-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0959-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0961-2014·2014-03-05

    Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk

    Teleflex Medical is recalling specific lots of ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising airway maintenance.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1070-2014·2014-03-05

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling Giraffe and Panda infant resuscitation systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1105-2014·2014-03-05

    Fresenius Recalls Optiflux B200 Flux Dialyzers Due to Port Leak Risk

    Fresenius Medical Care is recalling 100,008 Optiflux B200 Flux Dialyzers because the dialysate port may leak during priming.

    Product
    Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1077-2014·2014-03-05

    DePuy PFC SIGMA Knee Implant Recall Due to Microstructure Defects

    DePuy Orthopaedics is recalling PFC SIGMA knee implants with anomalous microstructure that may decrease fatigue strength and cause fracture.

    Product
    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1052-2014·2014-03-05

    Medline Recalls Surgical Kits with Potential Coating Defect on Guidewires

    Medline Industries is recalling 10 surgical kits containing guidewires with a potential coating defect. The kits were distributed to specific US states.

    Product
    STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2014·2014-03-05

    Fresenius Optiflux Dialyzers Recalled for Dialysate Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F160NRe dialyzers because the dialysate port may leak during priming. The recall covers 3.4 million units distributed in the US and Mexico.

    Product
    Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2014·2014-03-05

    Stryker Recalls Static Inserter Assemblies Due to Weld Fracture Complaints

    Stryker Spine is recalling 21 units of Specialty Straight Static Inserter Assemblies because customers reported fractures along the weld binding the handle to the shaft.

    Product
    Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wear Risk

    Philips is recalling HeartStart MRx monitor/defibrillators because therapy connections may wear prematurely, posing a risk to patients and caregivers.

    Product
    Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2014·2014-03-05

    Fresenius Optiflux F200A Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling 5,244 Optiflux F200A dialyzers due to a dialysate port leak during priming.

    Product
    Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2014·2014-03-05

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to Contamination

    Remel Inc is recalling specific lots of Oxoid Legionella BCYE Growth Supplement because the product may contain high levels of microbial contamination.

    Product
    Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1078-2014·2014-03-05

    GE Healthcare Wireless Digital Radiography Software Recall for Patient Safety

    GE Healthcare is recalling Wireless Digital Radiography Option (WDR1) software due to a defect that may cause patient exams to display incorrectly, potentially impacting patient safety.

    Product
    GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2014·2014-03-05

    Winco XL Convalescent Recliner Recalled Due to Assembly Defect

    Winco Mfg. is recalling 369 XL Convalescent Recliners due to a manufacturing defect in the right-hand recline mechanism that may cause loss of the position lock bar functionality.

    Product
    XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1116-2014·2014-03-05

    Winco Drop-Arm Convalescent Recliners Recalled for Mechanism Defect

    Winco Mfg. is recalling 369 drop-arm convalescent recliners due to a manufacturing defect that may cause the three-position lock bar to lose functionality.

    Product
    DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2014·2014-03-05

    Fresenius Optiflux F180NRe Dialyzers Recalled for Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F180NRe dialyzers because the dialysate port may leak during priming, potentially compromising treatment.

    Product
    Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2014·2014-03-05

    Winco Convalescent Recliners Recalled for Recline Mechanism Defect

    Winco Mfg. is recalling 369 convalescent recliners due to a manufacturing defect in the right hand recline mechanism that may cause the position lock bar to lose functionality.

    Product
    CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2014·2014-03-05

    Fresenius Optiflux F180NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F180NR dialyzers due to a dialysate port leak during priming. The recall covers 52,752 units distributed in the US and Mexico.

    Product
    Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide