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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Minimum severity

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

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21301–21325 of 27663

  • SevereFDA (Devices)·Z-2142-2016·2016-07-20

    Hospira LifeCare Pump Model 4200 PCA Infuser Recalled for Occlusion Detection Failure

    Hospira is recalling 6,268 LifeCare Pump Model 4200 PCA Infusers because they may fail to detect distal occlusions, a defect that caused one serious injury.

    Product
    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2140-2016·2016-07-20

    Hospira PCA 3 Infusion Pump Recall for Occlusion Detection Failure

    Hospira is recalling 8,216 PCA 3 infusion pumps because normal wear on a component may prevent the device from detecting distal occlusions, a defect that resulted in one serious injury.

    Product
    The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2139-2016·2016-07-20

    Hospira Recalls LifeCare PCA Plus II Infusion Pumps Due to Occlusion Detection Failure

    Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.

    Product
    The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2141-2016·2016-07-20

    Hospira Recalls LifeCare PCA Infusion Systems Due to Occlusion Detection Failure

    Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.

    Product
    LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2146-2016·2016-07-20

    Hardy Diagnostics Recalls QuickSlide MGS-80 Gram Stainers Due to Discrepant Results

    Hardy Diagnostics is recalling 25 QuickSlide MGS-80 and GramPRO-80 automated Gram stainers because they may produce discrepant culture and Gram stain results, potentially leading to misdiagnosis or improper patient treatment.

    Product
    QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2149-2016·2016-07-20

    Varian Optical Surface Monitoring System Recall for Unintended Couch Parameter Changes

    Varian Medical Systems is recalling Optical Surface Monitoring Systems (OSMS) used with TrueBeam EDGE because unintended changes to couch rotation parameters can occur during patient set-up.

    Product
    Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2016·2016-07-20

    Sorin Recalls Aortic Arch Cannulae Due to Incorrect Tip Angle

    Sorin Group USA is recalling Aortic Arch Cannulae because the distal tip angle is 15-20 degrees instead of the specified 45 degrees.

    Product
    AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of internal sutures, potentially causing the coils to stretch.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2016·2016-07-20

    Novarad NovaPACS Diagnostic Viewer Recall for Image Orientation Flipping

    Novarad Corporation is recalling NovaPACS Diagnostic Viewer software versions 7.4, 7.5, 7.6, and 8.0 because images may flip during streaming, potentially displaying incorrect orientation markers.

    Product
    NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2016·2016-07-20

    Medtronic Temporary Pacing Lead System Recalled for Design Non-Compliance

    Medtronic is recalling Temporary Pacing Lead Systems because they do not meet design standards preventing connection to hazardous voltage.

    Product
    Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2016·2016-07-20

    Stryker Recalls Specific Lots of Round Fluted Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of 6.0mm Round Fluted Burs due to potential tarnishing or corrosion that could cause inflammation requiring surgery.

    Product
    6.0mm Round Fluted Bur, Super Long
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2185-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2165-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2016·2016-07-20

    Varian AlignRT Plus Optical Surface Monitoring System Recall for Parameter Errors

    Varian Medical Systems is recalling AlignRT Plus systems because unintended changes to couch rotation parameters can occur during patient set-up.

    Product
    Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may cause the coils to stretch.

    Product
    Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of the internal sutures.

    Product
    Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2172-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide