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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33676–33700 of 40449

  • ModerateFDA (Devices)·Z-1033-2015·2015-02-11

    Express Diagnostics Recalls DrugCheck Ketamine Dip Tests for False Positives

    Express Diagnostics is recalling DrugCheck Ketamine Dip Tests because they may produce false positive results, leading to incorrect screening outcomes.

    Product
    DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1037-2015·2015-02-11

    FDA Recalls 16cm Minimally Invasive Attachment Due to Incorrect Color Bands

    The Anspach Effort, Inc. is recalling 8 units of the MIA16-G1 Minimally Invasive Attachment because customer complaints indicated the color bands were not correct.

    Product
    16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1013-2015·2015-02-04

    Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk

    Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.

    Product
    Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1022-2015·2015-02-04

    Innokas Medical VC150 Vital Signs Monitor Recalled for Alarm Failure

    Innokas Medical is recalling 20 VC150 Vital Signs Monitors because they may fail to issue visual and audible alarms when SpO2 or RRa values violate limits during mode switching.

    Product
    VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1011-2015·2015-02-04

    Philips BrightView MRI Systems Recalled for Unintended Movement

    Philips is recalling 1,064 BrightView MRI systems worldwide due to software issues causing unintended detector and gantry movement.

    Product
    BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2015·2015-02-04

    Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk

    Clinical Innovations, LLC is recalling 827 units of the Ebb Complete Tamponade System because of a potential for balloon leaks in lots manufactured since August 2014.

    Product
    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2015·2015-02-04

    Mobius Airo Mobile Intraoperative CT System Recalled for Data Transfer Errors

    Mobius Imaging is recalling 21 Airo Mobile Intraoperative CT systems because a software error may cause incorrect or missing navigation data to transfer to the Brainlab Curve system.

    Product
    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1031-2015·2015-02-04

    Baxter HomeChoice Peritoneal Dialysis Cycler Recalled for Keypad Malfunction

    Baxter Healthcare is recalling HomeChoice and HomeChoice Pro automated peritoneal dialysis cyclers because the keypad buttons may activate without being pressed.

    Product
    HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1020-2015·2015-02-04

    Sunrise Medical Recalls Six Quickie Q7 Adult Rigid Wheelchairs

    Sunrise Medical is recalling six Quickie Q7 Adult Rigid Wheelchairs because the height-adjustable handle may dislodge due to failing locking mechanisms.

    Product
    Quickie Q7 Adult Rigid Wheelchair Model EIR4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1023-2015·2015-02-04

    Beckman Coulter Lipase Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Lipase Assay kits because N-acetyl cysteine can cause falsely low results.

    Product
    Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1012-2015·2015-02-04

    Aesculap Miethke Shunt System Accessories Recalled for Incorrect MR Safety Labeling

    Aesculap, Inc. is recalling Miethke Shunt System accessories because the shelf box labels incorrectly display an MR conditional symbol. The product is actually MR unsafe, and the correct information is only provided in the Instructions for Use.

    Product
    Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1024-2015·2015-02-04

    Beckman Coulter Uric Acid Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Uric Acid Assay kits because N-acetyl cysteine administration can cause falsely low test results.

    Product
    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1026-2015·2015-02-04

    Beckman Coulter Lactate Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Lactate Assay kits because N-acetyl cysteine (NAC) administration can cause falsely low test results.

    Product
    Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1021-2015·2015-02-04

    Synthes 2.0 Mandible Locking Plate Bender Recall for Tip Breakage

    Synthes, Inc. is recalling 973 units of the 2.0 Mandible Locking Plate Bender/Cutter because the tips may break during use, potentially delaying surgery.

    Product
    2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1009-2015·2015-02-04

    Synthes Mandible External Fixator Recalled for Incorrect MR Safe Labeling

    Synthes, Inc. is recalling Mandible External Fixators because updated testing protocols mean the devices can no longer be designated MR Safe, despite previous labeling.

    Product
    The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1015-2015·2015-02-04

    Fresenius Medical Care Recalls Unqualified Hemodialysis Power Supply Assemblies

    Fresenius Medical Care is recalling 10 unqualified power supply assemblies for specific hemodialysis machines. The components were distributed in Oklahoma and Florida.

    Product
    ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1025-2015·2015-02-04

    Beckman Coulter Cholesterol Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Cholesterol Assay kits because N-acetyl cysteine administration can cause falsely low results.

    Product
    Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1027-2015·2015-02-04

    Siemens Syngo.plaza PACS Recalled for Potential Image Loss During System Crashes

    Siemens Medical Solutions is recalling 50 Syngo.plaza PACS systems because images may be lost if the system crashes before saving data to the hard disk.

    Product
    Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1010-2015·2015-02-04

    Baxter Recalls Four Lead TUR Irrigation Sets Due to Seal Failure Risk

    Baxter Healthcare is recalling 26,028 units of Four Lead TUR Irrigation Sets because the pouch packaging seal may fail at high altitudes.

    Product
    Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0955-2015·2015-02-04

    GE Healthcare Recalls Revolution CT Scanners Due to Missing Quality Control Test

    GE Healthcare is recalling 13 Revolution CT scanners because a required quality control test was not performed during installation.

    Product
    The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1032-2015·2015-02-04

    Fresenius Kabi Recalls HEPFLUSH-10 Heparin Lock Flush Solution Due to pH Failure

    Fresenius Kabi is recalling HEPFLUSH-10 heparin lock flush solution because a specific lot failed pH specifications. The recall covers 69,725 units distributed nationwide.

    Product
    HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1029-2015·2015-02-04

    Orthosensor Recalls Verasense Knee System Due to Inoperable Sensor Pad

    Orthosensor, Inc. is recalling 22 Verasense Knee System devices because one sensor pad is inoperable. The devices were distributed to six U.S. states.

    Product
    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-1028-2015·2015-02-04

    Smiths Medical Recalls Arterial Blood Sampling Kits Due to Labeling Error

    Smiths Medical ASD, Inc. is recalling 900 units of Portex Anaerobic Pulsator Arterial Blood Sampling Kits because the inner unit label displays an expiration date one year later than the actual date.

    Product
    Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1030-2015·2015-02-04

    Arrow Medical Kits Recalled for Incorrect Biopatch Dressing Size

    Arrow International Inc. is recalling specific medical kits because they were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

    Product
    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
    Category
    Medical Device
    Distribution
    Distributed nationwide