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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

29151–29175 of 40449

  • HighFDA (Devices)·Z-2766-2016·2016-09-14

    Hologic Recalls SureSight Obturator Introducer Localization Systems Due to Tip Breakage

    Hologic is recalling 535 units of SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

    Product
    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2016·2016-09-14

    Philips BrightView X Gamma Camera Recalled for Software Defect

    Philips Medical Systems is recalling 117 BrightView X gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2016·2016-09-14

    GE Healthcare Recalls SIGNA Creator and Explorer MRI Devices

    GE Healthcare is recalling SIGNA Creator and SIGNA Explorer MRI scanners due to an incorrect RF Power Monitor Function that could cause higher than expected thermal dose and localized heating to patients.

    Product
    GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2758-2016·2016-09-14

    Siemens e.cam and Symbia E Gamma Camera Patient Bed Recall

    Siemens is recalling e.cam and Symbia E gamma camera systems because patient hair can become caught in the patient bed drive mechanism.

    Product
    e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or interrupt therapy.

    Product
    Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2016·2016-09-14

    Invivo Xper Flex Cardio Patient Monitoring System Recalled for Frozen Display

    Invivo Corporation is recalling Xper Flex Cardio Patient Monitoring Systems because SpO2 and NIBP measurements may freeze on the display.

    Product
    The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2751-2016·2016-09-14

    Biomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency

    Biomet Microfixation is recalling 54 custom-made Hard Tissue Replacement implants due to a potential sterility deficiency. The affected units were distributed in the US and internationally.

    Product
    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2732-2016·2016-09-14

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Systems

    Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems due to a risk of specimen misidentification when the Primary Identifier is set to Tube Position ID.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2718-2016·2016-09-14

    ArjoHuntleigh Sara Combilizer Recalled for Potential Tipping Hazard

    ArjoHuntleigh is recalling 106 Sara Combilizer patient lifts due to a potential tipping hazard identified during internal testing. No adverse events or customer complaints have been reported to date.

    Product
    ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2733-2016·2016-09-14

    Integra Cranial Access Kits Recalled Due to Potential Sterility Compromise

    Integra LifeSciences is recalling Cranial Access Kits because product seals may open during distribution, rendering the devices unsterile.

    Product
    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2714-2016·2016-09-14

    Best Sanitizers Recalls Acecide-C High Level Disinfectant Due to Acid Degradation

    Best Sanitizers Inc is recalling specific lots of Acecide-C High Level Disinfectant & Sterilant because the acid solution is degrading faster than normal.

    Product
    Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2746-2016·2016-09-14

    Maquet Operating Room Table Connecting Bracket Recall for Welded Joint Failure

    Maquet is recalling Connecting Bracket (Fixture) Devices because post-market surveillance reports indicate the welded joint between the square mount and the first fixable swivel joint is broken.

    Product
    The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2725-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

    Product
    Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2769-2016·2016-09-14

    Innovision Innocor Cardiopulmonary Testing System Recalled for Electric Shock Risk

    Innovision A/S is recalling eight Innocor Cardiopulmonary Exercise and Lung Function Testing Systems to replace USB cables that lack galvanic isolation, preventing potential electric shock.

    Product
    Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2765-2016·2016-09-14

    Hologic Recalls SureSight Obturator Introducer Systems Due to Tip Breakage

    Hologic is recalling 1,440 SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

    Product
    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2737-2016·2016-09-14

    Philips BrightView XCT Upgrade Recalled for Potential Patient Contact

    Philips is recalling three BrightView XCT Upgrade units due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView XCT Upgrade Model 882454
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2729-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2734-2016·2016-09-14

    Omega Medical Imaging Recalls Elevating Monitor Suspension Systems

    Omega Medical Imaging is recalling 26 Elevating Monitor Suspension Systems because the suspension may separate from the lifting column bracket.

    Product
    2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2738-2016·2016-09-14

    Terumo Recalls Pinnacle Introducer Sheaths Due to Valve Leakage

    Terumo Medical Corporation is recalling Pinnacle Introducer Sheaths due to a manufacturing issue causing valve leakage, which poses a risk of incremental blood loss.

    Product
    PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2762-2016·2016-09-14

    Riverpoint Medical Recalls Webglo Polypropylene Surgical Sutures Due to Seal Issues

    Riverpoint Medical is recalling specific lots of Webglo polypropylene surgical sutures because the seals may open during distribution or packaging.

    Product
    Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2763-2016·2016-09-14

    Blackrock NeuroPort Biopotential Signal Processing System Recall for Labeling Error

    Blackrock Microsystems is recalling 81 Neural Signal Amplifiers because the device and patient cable are incorrectly labeled as Type CF Applied Parts.

    Product
    Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2764-2016·2016-09-14

    Blackrock NeuroPort Patient Cables Recalled for Incorrect Labeling

    Blackrock Microsystems is voluntarily recalling 120 Patient Cables because they are incorrectly labeled as Type CF Applied Parts.

    Product
    Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2742-2016·2016-09-14

    Siemens ADVIA Centaur PSA Assay Recall for Clinical Interpretation Clarification

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits to emphasize that PSA values must be interpreted according to current clinical guidelines for biochemical recurrence.

    Product
    ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2756-2016·2016-09-14

    Sorin Aortic Arch Cannula Recalled for Improper Tip Angle

    Sorin Group USA is recalling Aortic Arch Cannulas because the tip angle is less than the required 45 or 90 degrees.

    Product
    Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2747-2016·2016-09-14

    Mentor Breast Tissue Expanders Recalled Due to Product Mix-Up

    Mentor Texas, LP. is recalling 65 units of MENTOR CPX4 breast tissue expanders because a 350cc unit was found in a carton intended for 450cc units.

    Product
    MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide