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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34401–34425 of 40449

  • HighFDA (Devices)·Z-0489-2015·2014-12-10

    Gambro Recalls Polyflux Revaclear Dialyzers Due to Packaging Defects

    Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.

    Product
    Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2015·2014-12-10

    Alcon Recalls INFINITI Vision System Ultrasound FMS Due to Tubing Debris

    Alcon is recalling INFINITI Vision System Ultrasound FMS units because pieces of tubing may be present in the aspiration line.

    Product
    INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0496-2015·2014-12-10

    Cure Medical Recalls Pediatric Urinary Catheters Due to Labeling Error

    Cure Medical is recalling pediatric urinary catheters because some boxes are mislabeled as size 8 but contain size 10 catheters, posing a risk of injury.

    Product
    Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2015·2014-12-10

    Ethicon Recalls PERMA-HAND Silk Suture Due to Sterility Assurance Concerns

    Ethicon is recalling PERMA-HAND silk sutures because the company cannot ensure the products meet the expected sterility assurance level.

    Product
    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2015·2014-12-10

    Integra Selector Kit Tubing Recalled for Potential Irrigation Fluid Leakage

    Integra LifeSciences is recalling 6,358 Selector Kit tubing units because they may leak irrigation fluid during use if not placed correctly on the handpiece.

    Product
    Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0486-2015·2014-12-10

    Siemens Artis zee Angiography System Software Recall

    Siemens is recalling 1,131 Artis zee and zeego Angiography Systems due to a software issue that prevents deactivating the radiation block function after a network problem.

    Product
    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0487-2015·2014-12-10

    Beevers Cannulaide Model 101 Recalled for Incorrect Labeling

    Beevers Manufacturing recalled 393 units of Cannulaide Model 101 because the product was packed and labeled as Model 102.

    Product
    Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0480-2015·2014-12-10

    Stryker GDC 360 Coils Recalled for Expiration Date Violations

    Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped beyond their expiration dates.

    Product
    GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a)…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0481-2015·2014-12-10

    Stryker Neurovascular Recalls Expired Target Detachable Coils

    Stryker Neurovascular is recalling Target Detachable Coils shipped to US customers beyond their expiration date.

    Product
    Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: "…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0478-2015·2014-12-10

    Stryker GDC 360 Coils Recalled for Expiration Date Violations

    Stryker Neurovascular is recalling GDC 360 coils and related devices shipped to US customers beyond their expiration dates.

    Product
    GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0482-2015·2014-12-10

    Stryker Neurovascular Recalls Expired Gateway PTA Balloon Catheters

    Stryker Neurovascular is recalling Gateway PTA Balloon Catheters shipped to US customers beyond their expiration date.

    Product
    Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0502-2015·2014-12-10

    Aesculap Dual Switch Valve Recalled for Incorrect Expiration Date Labeling

    Aesculap, Inc. is recalling three Dual Switch Valves due to incorrect expiration dates on inner sterile bag labels. No patient injuries have been reported.

    Product
    The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0499-2015·2014-12-10

    Amerx Health Care Recalls Amerigel Daily Dressing Packets Due to Formulation Deviation

    Amerx Health Care Corp. is recalling 1,740 units of Amerigel Daily Dressing Packets due to a formulation deviation. The affected products were distributed nationwide and internationally.

    Product
    Amerigel Daily Dressing Packets Wound management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0500-2015·2014-12-10

    Amerx Recalls Amerigel Saturated Gauze Dressing Due to Formulation Deviation

    Amerx Health Care Corp. is recalling 21,108 units of Amerigel Saturated Gauze Dressing due to a formulation deviation. The products were distributed nationwide and internationally.

    Product
    Amerigel Saturated Gauze Dressing Wound management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0501-2015·2014-12-10

    Microgenics Recalls MAS CardioImmune XL Cardiac Marker Control Due to Variation

    Microgenics Corporation is recalling 2,135 vials of MAS CardioImmune XL Cardiac Marker Control (Lot CXL16011) because the product shows vial-to-vial variation for specific analytes.

    Product
    MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0479-2015·2014-12-10

    Stryker GDC 360 Coils Recalled for Expiration Date Violations

    Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped to US customers beyond their expiration dates.

    Product
    GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a)…
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0488-2015·2014-12-10

    CooperSurgical Cannula-Curette Recalled for Incorrect Curette Type

    CooperSurgical is recalling 30 units of the Cannula-Curette 12MM (Lot 147234) because the product contains an incorrect curette type.

    Product
    Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0472-2015·2014-12-03

    Toshiba Recalls Cardiac Function Analysis Software Due to Incorrect Results

    Toshiba American Medical Systems is recalling two units of cardiac function analysis software because it may display incorrect analysis results for heart function.

    Product
    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0206-2015·2014-12-03

    Philips Medical Systems Recalls Gel-E and Squishon Baby Support Products Due to Mold

    Philips Medical Systems is recalling Gel-E Donut and Squishon 2 baby support products because mold was found on the gel-filled items.

    Product
    Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0226-2015·2014-12-03

    Synthes Recalls Titanium Polyaxial Reduction Heads for Spine Screws

    Synthes (USA) Products LLC is recalling 24 Titanium Polyaxial Reduction Heads for Matrix Spine Screws because the inner diameter may not have been machined to the correct specification.

    Product
    Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0474-2015·2014-12-03

    Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Potential Result Errors

    Abbott Ireland Diagnostics Division is recalling 7,415 ARCHITECT Total T3 Reagent Kits because 17% of specific lots may produce patient results higher than expected.

    Product
    ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Cardiac Probe Grasper Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Cardiac Probe Graspers because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0468-2015·2014-12-03

    Summit J700 X-Ray Tube Stand Recalled for Insufficient Welds

    Summit Industries is recalling 32 J700 Floor Mounted Tube Stands because insufficient welds may cause breakage, leading to equipment damage or injury.

    Product
    The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system)…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0428-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Large Needle Driver Instruments

    Intuitive Surgical is recalling 509 8mm Large Needle Driver instruments due to potential surface degradation and accelerated mechanical wear caused by reprocessing deviations.

    Product
    8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states