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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32801–32825 of 40325

  • HighFDA (Devices)·Z-1802-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility

    Beaver-Visitec International is recalling 621 ophthalmic procedure kits because the included Devon Light Glove may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2015·2015-06-24

    Stryker Recalls Navigation System II-Cart Due to Weld Seam Defect

    Stryker is recalling 72 Navigation System II-Carts because a weld seam defect may cause the articulated arm joint to fail.

    Product
    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Defective Devon Light Gloves

    Beaver-Visitec International Inc. is recalling 268 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2015·2015-06-24

    Smiths Medical Recalls CADD-Solis Pumps Due to Locking Assembly Binding

    Smiths Medical is recalling CADD-Solis Ambulatory Infusion Pumps because the locking assembly may bind, preventing the cassette or keypad from locking securely.

    Product
    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility

    Beaver-Visitec International is recalling 585 ophthalmic procedure kits because the Devon Light Glove component may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2015·2015-06-24

    Synthes Pull Reduction Device Recalled for Potential Intraoperative Breakage

    Synthes, Inc. is recalling Pull Reduction Devices for 4.3mm Percutaneous Drill Guides because incorrect hardness specifications may cause the devices to break during surgery.

    Product
    Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2015·2015-06-24

    Integra Recalls Camino Intracranial Pressure Monitoring Catheters Due to Assembly Error

    Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Catheters because incorrect assembly may allow cerebrospinal fluid or blood to leak.

    Product
    Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2015·2015-06-24

    Mortara ELI 380 Electrocardiograph Recalled for Patient Data Mismatch Risk

    Mortara Instrument is recalling 176 ELI 380 electrocardiographs because ECG waveforms may be incorrectly associated with the wrong patient's demographics when transmitted to records systems.

    Product
    ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1811-2015·2015-06-24

    CareFusion Alaris PC Unit Infusion Pump Software Recall

    CareFusion 303, Inc. is recalling 63 Alaris PC unit model 8015 infusion pumps due to a software defect that may allow infusions to start outside hospital-established limits.

    Product
    Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2015·2015-06-24

    Neusoft NeuViz 64 CT Scanner Recalled for Teflon Compensator Failure

    Neusoft Medical System Co is recalling NeuViz 64 CT scanners because the Teflon A-plane compensator degrades under X-ray exposure, causing premature failure and image artifacts.

    Product
    Neusoft NeuViz 64 Multi-slice CT Scanner System
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1816-2015·2015-06-24

    BD Viper LT System Recalled for Potential False Positive Diagnostic Results

    Becton Dickinson is recalling seven BD Viper LT Systems due to the potential for false positive Chlamydia and Gonorrhea test results.

    Product
    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1803-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Procedure Kits with Defective Gloves

    Beaver-Visitec is recalling 384 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2015·2015-06-24

    Boston Scientific Recalls CLEARSIGN II Amplifiers Due to ECG Signal Interference

    Boston Scientific is recalling 43 CLEARSIGN II Amplifiers because blood pressure channel usage can cause ECG signals to become uninterpretable.

    Product
    CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1807-2015·2015-06-24

    Philips Q-Station Ultrasound Software Recalled for Data Integrity Issues

    Philips is recalling Q-Station ultrasound software because patient measurements may be incorrectly appended to other patients' studies.

    Product
    Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Defective Sterile Gloves

    Beaver-Visitec is recalling 214 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2015·2015-06-24

    Medtronic Passive Planar Blunt Probe Recalled Due to Sharp Tip Defect

    Medtronic is recalling 18 Passive Planar Blunt Probes because they were manufactured with sharp tips instead of blunt tips. The devices are used in navigated surgery.

    Product
    Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1795-2015·2015-06-24

    Neuro Kinetics Recalls I-Portal NOTC and VNG Devices Due to Malfunction

    Neuro Kinetics is recalling 140 I-Portal NOTC and VNG devices due to system malfunctions and unintended sudden movements at startup. No injuries have been reported.

    Product
    I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1808-2015·2015-06-24

    AMUSA Sterile Field Flush Syringe Recalled for Incorrect Expiration Date Labeling

    MRP, LLC dba AMUSA is recalling 1,080 units of T/S2 0.9% Sodium Chloride Injection flush syringes due to incorrect expiration date labeling.

    Product
    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1800-2015·2015-06-24

    Synthes Recalls 3.7mm Cannulated Screws Due to Incorrect Labeling

    Synthes, Inc. is recalling 54 units of 3.7mm Cannulated Locking and Conical Screws because certain lots were found to have been labeled incorrectly.

    Product
    3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1798-2015·2015-06-24

    Biomet Vanguard M Unicondylar Tibial Trial Recalled for Incorrect Etching

    Biomet, Inc. is recalling 27 Vanguard M Unicondylar Tibial Trials because the left and right orientation markings are incorrectly etched on the handle.

    Product
    Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1814-2015·2015-06-24

    CooperSurgical Recalls MILEX OMNIFLEX Diaphragms Due to Packaging Error

    CooperSurgical is recalling 200 units of MILEX OMNIFLEX Diaphragms because size 80 boxes were incorrectly packaged with size 85 diaphragms.

    Product
    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
    Category
    Medical Device
    Distribution
    13 states
  • CriticalFDA (Devices)·Z-1726-2015·2015-06-17

    HeartWare Ventricular Assist System Recalled for Driveline Connector Pin Retraction

    HeartWare Inc is recalling HVAD systems due to complaints about pin retraction within the driveline connector. The recall affects 3,747 units currently in use worldwide.

    Product
    HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • CriticalFDA (Devices)·Z-1706-2015·2015-06-17

    Maquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk

    Maquet is recalling FLOW-i Anesthesia Systems because a dislodged patient cassette can cause gas leakage and stop ventilation.

    Product
    FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-1767-2015·2015-06-17

    Philips Medical Systems Recalls Extended Brilliance Workstation UPS Accessories

    Philips Medical Systems is recalling Extended Brilliance Workstation UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide