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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24301–24325 of 40299

  • LowFDA (Devices)·Z-1358-2018·2018-04-18

    Aesculap Recalls Doyen-Collin Mouth Gags Due to Sticking Plastic Sleeves

    Aesculap Implant Systems LLC is recalling Doyen-Collin Mouth Gags because plastic sleeves may stick together, rendering the instruments unusable.

    Product
    Doyen-Collin Mouth Gag 120MM/ General Instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1352-2018·2018-04-18

    Magstim Rapid Therapy System Recalled for Missing User Manuals

    The Magstim Company Limited is recalling 43 Magstim Rapid Therapy Systems because user manuals were not supplied with the devices.

    Product
    Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1322-2018·2018-04-18

    Clinical Diagnostic Systems Recalls VITROS TSH Reagent Packs Due to Calibration Issues

    Clinical Diagnostic Systems is recalling specific lots of VITROS TSH Reagent Packs because they may generate higher-than-expected calibrator signals, potentially causing calibration curves to fall outside quality parameters.

    Product
    VITROS Immunodiagnostic Products TSH Reagent Pack
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1350-2018·2018-04-18

    Neuropro Spinal Jaxx Interbody Fusion Device Recall for Incorrect Size Etching

    Neuropro Spinal Jaxx is recalling six Spinal Jaxx Interbody Fusion Devices because the implant size is incorrectly etched on the device, although the box label is correct.

    Product
    Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1359-2018·2018-04-18

    Aesculap Strauss Penis Clamp Recalled Due to Sticking Plastic Sleeves

    Aesculap Implant Systems LLC is recalling Strauss Penis Clamps because plastic sleeves may stick together, rendering the instruments unusable.

    Product
    Strauss Penis Clamp 130MM/General Instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2018·2018-04-11

    GE Healthcare Recalls Monica Novii Wireless Patch System Due to Signal Swap Risk

    GE Healthcare is recalling 1,742 units of the Monica Novii Wireless Patch System because incorrectly reconnected cables may cause fetal and maternal heart rate signals to be displayed swapped.

    Product
    Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2018·2018-04-11

    Fresenius K2 Hemodialysis Machines Recalled for SLED Program Software Defect

    Fresenius Medical Care is recalling 127 K2 Hemodialysis Machines because a software defect may allow the ultrafiltration pump to run at unsafe rates during SLED treatments.

    Product
    2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1280-2018·2018-04-11

    Baxter Recalls Prismaflex Control Units Due to Software and Usage Issues

    Baxter Healthcare is recalling 3,440 Prismaflex Control Units worldwide due to reports of operators failing to follow safe unloading instructions and software errors in specific versions.

    Product
    Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2018·2018-04-11

    C.R. Bard Recalls HydroSil Gripper Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling specific lots of HydroSil Gripper Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.

    Product
    HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2018·2018-04-11

    DePuy Spine Recalls Confidence Plus Kit Spinal Cement System Lots

    DePuy Spine is recalling specific lots of the Confidence Plus Kit Spinal Cement System because they may contain incorrect amounts of contrast medium, making the product difficult or impossible to visualize on x-ray.

    Product
    Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1308-2018·2018-04-11

    C.R. Bard Recalls Magic 3 Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling Magic 3 Intermittent Catheters because some units were caught in the sterile barrier seal or cut.

    Product
    Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2018·2018-04-11

    Seiler Alpha Air 6 ENT Microscope Recalled for Tipping Hazard

    Seiler Instruments is recalling Alpha Air 6 ENT Microscopes because they may tip over if attachments are extended and the device is moved improperly.

    Product
    Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1293-2018·2018-04-11

    GE Healthcare Recalls Monica IF24 Interface System Due to Signal Swap Risk

    GE Healthcare is recalling 355 Monica IF24 Interface Systems because incorrectly reconnected cables can cause fetal and maternal heart rate signals to be displayed incorrectly.

    Product
    Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2018·2018-04-11

    Magellan LeadCare Plus Blood Lead Analyzer Recalled for Battery Overheating Risk

    Magellan Diagnostics is recalling 79 LeadCare Plus Blood Lead Analyzers because incorrect battery placement may cause overheating and potential finger burns.

    Product
    LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1295-2018·2018-04-11

    Magellan LeadCare II Blood Lead Analyzer Recalled for Battery Overheating Risk

    Magellan Diagnostics is recalling LeadCare II Blood Lead Analyzers because incorrect battery placement may cause overheating and potential finger burns.

    Product
    LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1279-2018·2018-04-11

    Life Technologies Recalls Oncomine Dx Target Test User Guides

    Life Technologies is recalling Oncomine Dx Target Test user guides and assay definition files because they may report erroneous results when used off-label for non-NSCLC samples.

    Product
    Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1289-2018·2018-04-11

    Invivo DynaCAD Software Recalled for Incorrect Pharmacokinetic Map Display

    Invivo Corporation is recalling DynaCAD software versions 3.4 and 3.5 because pharmacokinetic and ADC maps may display incorrectly on remote clients, potentially leading to underestimated values.

    Product
    DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1309-2018·2018-04-11

    C.R. Bard Recalls Personal Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling Personal Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.

    Product
    Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2018·2018-04-11

    Dynavox T15 Speech Generating Device Recalled Due to Battery Defect

    Dynavox Systems LLC is recalling 307 T15 Speech Generating Devices because the integral battery may out-gas and swell after long periods of disuse, potentially causing the device case to separate.

    Product
    Dynavox T15 Speech Generating Device ( including Batteries)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1288-2018·2018-04-11

    Southmedic Oxygen Masks Recalled Due to Potential CO2 Diffuser Issues

    Southmedic, Inc. is recalling specific oxygen masks with EtCO2 sampling lines because loose or missing CO2 diffusers may render the masks non-functioning.

    Product
    Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1301-2018·2018-04-11

    Binding Site Optilite Beta-2-Microglobulin Urine Kit Recalled for Performance Defect

    The Binding Site Group is recalling 20 Optilite Beta-2-Microglobulin Urine Kits because they do not meet the stated antigen excess protection claim.

    Product
    Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1281-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling 930 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life instead of 24 months.

    Product
    Radial Artery Catheterization Kit; Model: AK-04018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1302-2018·2018-04-11

    GE Healthcare Recalls Centricity PACS-IW Due to Image Data Loss Risk

    GE Healthcare is recalling 569 units of Centricity PACS-IW because a database error may cause image series to be missing from exams without user notification.

    Product
    GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1277-2018·2018-04-11

    Halyard Health Recalls CORTRAK 2 Nasogastric Feeding Tubes

    Halyard Health is recalling CORTRAK 2 feeding tubes because the internal stylet may be visible in the exit port window, deviating from specifications.

    Product
    CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement.

    Product
    Radial Artery Catheterization Kit; Model: AK-04020
    Category
    Medical Device
    Distribution
    Distributed nationwide