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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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24401–24425 of 27699

  • HighFDA (Devices)·Z-0031-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues

    Navilyst Medical is recalling specific BioFlo PICC kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2015·2014-10-15

    Richard Wolf Recalls Hulka Clip Tubal Occluding Device Lot 51000232

    Richard Wolf Medical Instruments is recalling Hulka Clip Tubal Occluding Devices (Lot 51000232) due to a biocompatibility test discrepancy found in a subsequent lot.

    Product
    The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2714-2014·2014-10-08

    Teleflex Recalls Hudson Pediatric Anesthesia Breathing Circuits Due to Cracking

    Teleflex Medical is recalling Hudson RCI Pediatric Anesthesia Breathing Circuits because they can crack prior to and during use.

    Product
    Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2015·2014-10-08

    Siemens Ysio Max Radiographic Systems Recalled for Image Loss Risk

    Siemens is recalling Ysio Max radiographic systems because a malfunction can cause images to be lost, requiring patients to repeat examinations.

    Product
    Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2015·2014-10-08

    Siemens AXIOM Luminos dRF Max Systems Recalled for Image Loss Risk

    Siemens is recalling AXIOM Luminos dRF Max systems due to malfunctions that cause lost images and incorrect labels, potentially leading to repeated examinations.

    Product
    Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0004-2015·2014-10-08

    Siemens Uroskop Omnia Max X-Ray System Recalled for Image Loss

    Siemens is recalling two Uroskop Omnia Max systems because a malfunction causes image loss and incorrect labels, leading to repeated examinations.

    Product
    Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0005-2015·2014-10-08

    Siemens Medical Imaging Systems Recalled for Image Loss and Labeling Errors

    Siemens is recalling five Luminos Agile Max systems due to malfunctions that cause image loss and incorrect labels, leading to repeated examinations.

    Product
    Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2737-2014·2014-10-08

    Zimmer Recalls Persona Knee System Female Screws Due to Stripping Risk

    Zimmer, Inc. is recalling 16,380 units of Persona The Personalized Knee System 2.5 mm Female Screws due to potential stripping of the hex driver when used in cortical bone.

    Product
    Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2733-2014·2014-10-08

    Lumenis Array LaserLink Recall for Erroneous Retinal Pattern Display

    Lumenis is recalling 16 Array LaserLink laser system accessories because they may project an incorrect pattern on the retina during treatment.

    Product
    Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2014·2014-10-08

    Intuitive Surgical Recalls da Vinci Xi Patient Side Carts Due to Sensor Failure

    Intuitive Surgical is recalling 75 da Vinci Xi Patient Side Carts because a motor sensor failure can occur after a mid-procedure restart.

    Product
    ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2713-2014·2014-10-08

    Siemens Symbia Intevo SPECT/CT Systems Recalled for Rubber Isolator Aging

    Siemens Medical Solutions is recalling 48 Symbia Intevo SPECT/CT systems because a rubber isolator may degrade over time, potentially leading to drive belt rupture.

    Product
    The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping.…
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2738-2014·2014-10-08

    Baxter SPECTRUM Pump Recall Due to Service Technician Error

    Baxter Healthcare is recalling SPECTRUM Pumps because a service technician may not have followed established procedures between May 5 and June 3, 2014.

    Product
    SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0001-2015·2014-10-08

    Invivo Recalls Philips MRI Patient Monitoring Systems Due to Metal Debris

    Invivo is recalling 10 Philips MRI Patient Monitoring Systems because metal debris found during production could cause power failures and loss of patient monitoring.

    Product
    Philips Expression MR200 MRI Patient Monitoring System Model 866120
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2621-2014·2014-10-01

    ICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk

    ICU Medical is recalling 100 units of ConMed Stat 2 flow controllers because they may deliver a significantly higher flow rate than intended.

    Product
    83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2685-2014·2014-10-01

    Nanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors

    Nanosphere is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.

    Product
    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from…
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-2620-2014·2014-10-01

    ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate Risk

    ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.

    Product
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2702-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks

    Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2014·2014-10-01

    ICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues

    ICU Medical is recalling specific IV administration sets because the Stat 2 flow controller may deliver a significantly higher flow rate than intended.

    Product
    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2593-2014·2014-10-01

    CareFusion EnVe and ReVel Ventilators Recalled for Power Connector Damage Risk

    CareFusion is recalling 1,729 EnVe and ReVel ventilators because operator misconnection can damage the power connector, potentially shorting the power adapter.

    Product
    CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2014·2014-10-01

    ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate

    ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.

    Product
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2707-2014·2014-10-01

    Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode

    Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.

    Product
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2695-2014·2014-10-01

    PDG Fuze Manual Tilt Wheelchairs Recalled for Axle Plate Detachment Risk

    PDG Product Design Group is recalling Fuze T50, T20, and T50 Jr manual tilt wheelchairs because a hex bolt head might shear, causing the axle plate to detach and the wheels to collapse.

    Product
    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2698-2014·2014-10-01

    Argon UltraStream Hemodialysis Catheter Recalled for Luer Cracking

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because cracks may develop on the red arterial luer during attachment or manipulation.

    Product
    UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2675-2014·2014-10-01

    Peters Surgical Recalls CARDIOXYL Sutures Due to Surface Treatment Splitting

    Peters Surgical is recalling 4,976 units of CARDIOXYL synthetic surgical sutures because a potential splitting of the surface treatment on thread ends was identified.

    Product
    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and…
    Category
    Medical Device
    Distribution
    Distributed nationwide