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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35751–35775 of 40449

  • HighFDA (Devices)·Z-1713-2014·2014-06-11

    Arrow Percutaneous Sheath Introducer Kits Recalled for Dilator Tip Damage

    Arrow International Inc is recalling specific Percutaneous Sheath Introducer Kits due to dilator tip damage that could cause vessel injury.

    Product
    Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2014·2014-06-11

    Hospira Infusion Pumps Recalled for Door Roller Assembly Defect

    Hospira is recalling specific Plum XL and Micro Macro infusion pumps because a door roller assembly may break, preventing the cassette from locking properly.

    Product
    Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2014·2014-06-11

    FDA Recalls Bard Ventralight ST Mesh Due to Potential Sterility Compromise

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2014·2014-06-11

    Medtronic Ascenda Intrathecal Catheter Recalled for Endotoxin Contamination

    Medtronic is recalling Model 8780 Ascenda Intrathecal Catheters because they may contain endotoxin levels exceeding USP limits.

    Product
    Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1678-2014·2014-06-11

    Philips IntelliSpace Portal Software Recall for SPECT Reconstruction Errors

    Philips Medical Systems is recalling IntelliSpace Portal software because SPECT reconstructions may lack scatter correction or apply resolution recovery incorrectly.

    Product
    IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2014·2014-06-11

    Siemens AXIOM Luminos dRFsystem Recalled for Electrostatic Discharge Risk

    Siemens is recalling 37 AXIOM Luminos dRF diagnostic imaging systems because electrostatic discharges may trigger unintended movement, posing a danger to patients and personnel.

    Product
    AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1694-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterility Compromise

    Davol, Inc. is recalling Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2014·2014-06-11

    Hospira Recalls LifeCare 5000 Infusion Pumps Due to Door Roller Defect

    Hospira is recalling LifeCare 5000 infusion pumps because a broken door roller pin may prevent the door from locking the cassette properly, potentially causing alarms or false occlusions.

    Product
    LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2014·2014-06-11

    Philips CT Scanners Recalled for Disengaged Service Latch

    Philips Medical Systems is recalling 6,839 CT scanners worldwide because a service latch may disengage, causing the table top to become free-floating.

    Product
    Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2014·2014-06-11

    Cincinnati Sub-Zero Recalls 115 V Blanketrol II Hyper-Hypothermia Systems

    Cincinnati Sub-Zero is recalling seven 115 V Blanketrol II Hyper-Hypothermia Systems due to an incorrect voltage component that may prevent the device from maintaining patient temperature during cooling.

    Product
    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1701-2014·2014-06-11

    Hologic M-IV Mammography System Recalled for Defective Emergency Off Switch

    Hologic is recalling three M-IV Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.

    Product
    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1673-2014·2014-06-11

    Bayer Medrad Continuum MR Infusion System Recall for Damaged Locking Pins

    Bayer is recalling non-wireless Medrad Continuum MR Infusion Systems shipped before March 2008 due to potentially damaged locking pins in the bracket.

    Product
    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2014·2014-06-11

    CP Medical Recalls Monoswift PGCL Sutures for Tensile Strength Failure

    CP Medical is recalling one lot of Monoswift PGCL absorbable sutures because they failed to meet USP minimum tensile strength requirements.

    Product
    Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek¿ pouch. It is an undyed, monofilament synthetic absorbable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2014·2014-06-11

    Bard Composix LIP Mesh Recall Due to Potential Sterility Compromise

    Davol, Inc. is recalling Bard Composix LIP Mesh with Echo PS because the sterile inflation assembly packaging may be open or have a weak seal.

    Product
    Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2014·2014-06-11

    LAP Laser Software Recall Due to Incorrect Patient Marking Instructions

    LAP of America is recalling CARINAsim and CARINAiso laser software manuals due to errors that may cause incorrect patient marking.

    Product
    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1707-2014·2014-06-11

    Brainlab ExacTrac 5.5 Image Processing System Recalled for Plan Blending Error

    Brainlab AG is recalling ExacTrac 5.5 image processing systems because a specific workflow may generate unintended blends of separate patient treatment plans.

    Product
    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2014·2014-06-11

    Siemens Ysio Systems Recalled for Potential Unintended Radiation Release

    Siemens is recalling 433 Ysio radiographic systems because excessive cleaning liquid usage may cause a short circuit, leading to unintended radiation release.

    Product
    Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2014·2014-06-11

    Aesculap Miethke Ventricular Catheter Recalled Due to Deflector Movement Issues

    Aesculap, Inc. is recalling 48 units of the Miethke Ventricular Catheter with Deflector because the deflector did not move freely in three reported cases.

    Product
    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1704-2014·2014-06-11

    Hospira Recalls Infusion Pumps Due to Door Roller Assembly Breakage Risk

    Hospira is recalling specific Plum XL and LifeCare infusion pumps because a door roller assembly may break, preventing the cassette door from locking properly.

    Product
    Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Pouch Seal Failure

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS due to potential pouch seal failures that could compromise sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1720-2014·2014-06-11

    Small Bone Innovations Recalls Non-Sterile RingFIX Olive Wires

    Small Bone Innovations is recalling non-sterile RingFIX Olive Wires because they were packaged with the wrong internal component.

    Product
    SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1696-2014·2014-06-11

    Bard Ventralight ST Mesh Recalled for Potential Sterile Pouch Seal Defects

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may have an open or weak seal.

    Product
    Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2014·2014-06-11

    Synthes XRL Medium Trial Central Body Recalled for Incorrect Dimension Etching

    Synthes, Inc. is recalling two lots of the Synthes XRL Medium Trial-Central Body device because they were incorrectly etched with the wrong height dimensions.

    Product
    Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1695-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Failure

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 8" Circle because the sterile pouch holding the inflation assembly may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide