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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24351–24375 of 27663

  • HighFDA (Devices)·Z-0023-2015·2014-10-15

    Biomedix SELEC-3 I.V. Administration Set Recalled Due to Adhesive Failure

    Biomedix is recalling SELEC-3 I.V. Administration Sets because insufficient glue application caused the sets to fail.

    Product
    Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0028-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Defects

    Navilyst Medical is recalling 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, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2015·2014-10-15

    ZOLL Pro-padz Sterile Adult Electrodes Recalled Due to Sterility Concerns

    Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 193 cases distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2015·2014-10-15

    ArjoHuntleigh Contoura C1000 and C1080 Bariatric Beds Recalled for Entrapment Risk

    Arjo Hospital Equipment AB is recalling 1,695 Contoura C1000 and C1080 bariatric beds worldwide due to a low but existing risk of patient entrapment for individuals with a BMI under 40.

    Product
    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2015·2014-10-15

    DePuy Charnley Pin Retractor and Handle Set Recalled for Component Breakage

    DePuy Orthopaedics is recalling 65 units of the Charnley Pin Retractor and Handle Set because the small extraction peg is breaking from the pin.

    Product
    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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