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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38576–38600 of 40449

  • SevereFDA (Devices)·Z-1168-2013·2013-05-01

    GE Healthcare Recalls Ventri Discovery NM 530c Nuclear Imaging Systems

    GE Healthcare is recalling 556 Ventri Discovery NM 530c nuclear imaging systems because a moving table mechanism can pinch patient fingers during an exam.

    Product
    Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-1157-2013·2013-05-01

    Spinal Solutions Recalls APLIF Implants Due to Inadequate Testing

    Spinal Solutions is recalling 220 APLIF implants because they lack adequate testing to prove safety. The defect could cause implant breakage or movement.

    Product
    APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1156-2013·2013-05-01

    Orthopedic Alliance Recalls Blue & Gold Spine System Implants

    Orthopedic Alliance LLC is recalling Blue & Gold Spine System implants and instruments because the system lacks adequate testing and documentation to demonstrate it meets performance or safety standards.

    Product
    Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1167-2013·2013-05-01

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Recalled for Software Error

    Beckman Coulter is recalling 490 AU5800 Clinical Chemistry Analyzers due to a software error that may cause the system to misidentify samples and report erroneous patient results.

    Product
    AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1154-2013·2013-05-01

    Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages

    Nova Biomedical Corporation is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.

    Product
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2013·2013-05-01

    Ortho-Clinical Diagnostics Recalls VITROS Phenobarbital Slides Due to Accuracy Issues

    Ortho-Clinical Diagnostics is recalling VITROS Phenobarbital Slides because they may produce inaccurate, positively biased patient results that quality controls might miss.

    Product
    VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2013·2013-05-01

    GE Healthcare Recalls Xeleris 2 Workstation Due to Software Artifact Risk

    GE Healthcare is recalling 11 Xeleris 2 Processing & Review Workstations due to a software issue that may cause image artifacts in MPI studies, potentially leading to misdiagnosis.

    Product
    GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT)…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1165-2013·2013-05-01

    Philips NeuViz 16 CT Scanner Recalled Due to Pinch Hazard

    Philips and Neusoft are recalling 23 NeuViz 16 CT scanners because a user error could cause personnel injuries, including a reported finger pinch.

    Product
    NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2013·2013-05-01

    Philips NeuViz Dual CT Scanner Recalled for Pinch Hazard

    Philips and Neusoft are recalling 25 NeuViz Dual CT scanners because user error can cause personnel injuries, including a reported finger pinch.

    Product
    NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2013·2013-05-01

    Accuray RoboCouch Patient Positioning System Recalled for Defective Gearboxes

    Accuray Incorporated is recalling 16 RoboCouch Patient Positioning Systems because A5 gearboxes responsible for pitch and roll motions may be defective.

    Product
    RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1153-2013·2013-05-01

    Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages

    Nova Biomedical is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.

    Product
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1080-2013·2013-05-01

    Stellate Systems Recalls Harmonie Software Due to FDA Clearance Issues

    Stellate Systems is recalling Harmonie software versions 5.1 to 6.2e because the product's labeling indications have not been cleared by the FDA for sale in the USA.

    Product
    Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2013·2013-05-01

    Varian RPM Respiratory Gating System Recall for Waveform Anomaly

    Varian is recalling RPM Respiratory Gating System v1.7.5 units because they may produce inverted respiratory waveforms during specific sessions.

    Product
    Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1173-2013·2013-05-01

    DePuy Mitek Recalls Blue Orthocord Sutures Due to Inaccurate Strength Labeling

    DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state they retain 100% strength at six weeks, when they actually retain approximately 80%.

    Product
    ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1178-2013·2013-05-01

    Alere Cholestech LDX hsCRP Test Cassette Recall for Imprecision

    Alere San Diego, Inc. is recalling 2,333 Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassettes due to increased imprecision that may affect quantitative results.

    Product
    The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1174-2013·2013-05-01

    DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling

    DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.

    Product
    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1158-2013·2013-05-01

    Teleflex Medical Recalls Belly Bag Urine Collection Bags Due to Packaging Concerns

    Teleflex Medical is recalling 190,103 sterile Belly Bag Urine Collection Bags with Hip Belts because the sterile packaging may be compromised.

    Product
    Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1172-2013·2013-05-01

    DePuy Mitek Recalls Blue Orthocord Sutures Due to Inaccurate Labeling

    DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state that 100% suture strength remains at six weeks.

    Product
    ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1175-2013·2013-05-01

    DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling

    DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.

    Product
    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1176-2013·2013-05-01

    DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling

    DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.

    Product
    ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1161-2013·2013-05-01

    Ortho-Clinical Diagnostics Recalls Vitros Anti-HBs Reagent Packs Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling specific lots of Vitros Anti-HBs Reagent Packs because they may fail to obtain a valid calibration.

    Product
    VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1162-2013·2013-05-01

    Sirtex SIR-yttrium 90 microspheres recalled for incorrect expiration date

    Sirtex Medical Limited is recalling 21 doses of SIR-yttrium 90 microspheres due to an incorrect expiration date. The product is used to treat unresectable metastatic liver tumors.

    Product
    Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1116-2013·2013-04-24

    Hospira GemStar Infusion Pump Recall for Potential Over-Infusion Risk

    Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, potentially causing over-infusion of medication.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1052-2013·2013-04-24

    Stryker Recalls ShapeMatch Cutting Guides Due to Internal Process Issues

    Stryker Orthopaedics is recalling ShapeMatch Cutting Guides used in knee surgeries due to potential issues with internal planning and production processes.

    Product
    ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1150-2013·2013-04-24

    Advanced Sterilization Products Recalls EVOTECH Endoscope Cleaner Due to Smoke Risk

    Advanced Sterilization Products is recalling 761 EVOTECH Endoscope Cleaner and Reprocessor systems because a circuit board malfunction can cause smoke to emanate from the device.

    Product
    EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
    Category
    Medical Device
    Distribution
    Distributed nationwide