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)

Clear filters

33401–33425 of 40449

  • ModerateFDA (Devices)·Z-1309-2015·2015-04-01

    Aaren Scientific Recalls Intraocular Lenses Due to Non-Compliant Instructions

    Aaren Scientific is recalling 28 intraocular lenses because the instructions for use do not fully comply with US requirements.

    Product
    Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1323-2015·2015-04-01

    ArthroCare Recalls 15 Coblator II Systems Due to Component Reversal

    ArthroCare Medical Corporation is recalling 15 Coblator II systems because specific components were reversed on the controller boards.

    Product
    Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1319-2015·2015-04-01

    In2Bones Recalls DUAFIT Interphalangeal Implants Due to Dimensional Non-Conformity

    In2Bones is recalling 15 DUAFIT interphalangeal implants because dimensional non-conformity prevents them from fitting into their dedicated holders.

    Product
    DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1321-2015·2015-04-01

    Siemens ADVIA Chemistry Systems Drug Calibrator I Recalled for Incorrect Values

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, due to incorrect calibrator values for Phenytoin 2 and Phenobarbital 2 assays.

    Product
    ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1318-2015·2015-04-01

    In2Bones Recalls DUAFIT Interphalangeal Implants Due to Dimensional Non-Conformity

    In2Bones is recalling 35 units of DUAFIT PIP 0o CA Size 2 interphalangeal implants because dimensional non-conformity prevents them from fitting into the dedicated holder.

    Product
    DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1315-2015·2015-04-01

    Leica CD15 Antibody Recalled for Decreasing Staining Intensity

    Leica Microsystems is recalling 309 units of CD15 antibody because staining intensity decreases over shelf life.

    Product
    Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2015·2015-04-01

    Roche Recalls cobas EGFR Mutation Test Kits Due to False Positives

    Roche Molecular Systems is recalling 190 kits of the cobas EGFR Mutation Test because they may produce false positive results for Exon 20 insertion mutations.

    Product
    cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1282-2015·2015-03-25

    Siemens LANTIS Oncology Servers Recalled for Potential Treatment Errors

    Siemens is recalling 87 LANTIS Oncology Information System servers because using unvalidated operating systems may lead to incorrect patient treatment.

    Product
    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1288-2015·2015-03-25

    Ossur LP Rotate Foot System Recalled for Insecure Assembly

    Ossur H / F is recalling LP Rotate Foot System prosthetic devices because short threads on the shock module may cause it to detach, leading to falls.

    Product
    LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1276-2015·2015-03-25

    Medtronic FlexCath Select Steerable Sheath Recalled for Valve Debris

    Medtronic is recalling 151 FlexCath Select Steerable Sheaths because clinicians observed debris originating from the hemostasis valve outside of patients' bodies.

    Product
    Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2015·2015-03-25

    Siemens ARTISTE MV System Linear Accelerator Recalled for Software Issue

    Siemens is recalling three ARTISTE MV System linear accelerators due to a software issue that may cause a dark current phenomenon during specific cancer treatments.

    Product
    ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1298-2015·2015-03-25

    CooperSurgical Infant Heel Gel Warmers Recalled for Burn Risk

    CooperSurgical is recalling Infant Heel Gel Warmers and The Infant Heel Warmer because products without expiration dates have a remote potential for minor burns.

    Product
    CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2015·2015-03-25

    Stryker Recalls Triathlon Distal Capture Assembly Due to Weld Disassociation Risk

    Stryker Howmedica Osteonics is recalling 2,030 Triathlon Distal Capture Assemblies because a weld may disassociate, potentially causing the trigger mechanism to become loose or disassociated.

    Product
    Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2015·2015-03-25

    GE Healthcare Treadmill T2100 and T2000 Power Cord Recall

    GE Healthcare is recalling T2100 and T2000 treadmills due to a potential safety issue with the power cord assembly.

    Product
    GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1238-2015·2015-03-25

    Elekta Precise Treatment Table Recalled for Positioning Error Risk

    Elekta is recalling Precise Treatment Tables because incorrect sensor installation during maintenance can cause undetected positioning errors, potentially leading to clinical mistreatment.

    Product
    Elekta Precise Treatment Table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2015·2015-03-25

    Synthes Thumb Screws Recalled Due to Incorrect Stainless Steel Material

    Synthes, Inc. is recalling 183 thumb screws for orthopedic aiming arms because incorrect raw material was used, which may lead to stress-corrosion cracking.

    Product
    Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2015·2015-03-25

    CooperSurgical Recalls MediChoice Infant Heel Warmers for Burn Risk

    CooperSurgical is recalling MediChoice Infant Heel Warmers because products without expiration dates have a remote potential for minor burns.

    Product
    MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2015·2015-03-25

    Mindray Recalls Passport V Monitors Due to Inaccurate Blood Pressure Readings

    Mindray is recalling 519 Passport V Monitors because the invasive blood pressure function may provide incorrect measurements.

    Product
    Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling 16,410 units of BD PosiFlush Saline Flush Syringes included in various device kits because open seals may impact product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain catheter kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in various catheter kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2015·2015-03-25

    GE Healthcare Ventilators Recalled for Caster Mounting Hardware Failure Risk

    GE Healthcare is recalling specific ventilator models due to a potential failure of the caster mounting hardware that could cause the device to fall or tip over.

    Product
    GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2015·2015-03-25

    Baxter MiniCap with Povidone-Iodine Solution Recalled for Sponge Defects

    Baxter Healthcare is recalling MiniCap with Povidone-Iodine Solution units for hemodialysis because the product may have separating or protruding sponges.

    Product
    MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2015·2015-03-25

    Puritan Absorbent Foam Tipped Applicator Recall Due to Shaft Breakage

    Puritan Medical Products is recalling sterile absorbent foam tipped applicators because the shafts may break, preventing adequate patient specimen collection.

    Product
    Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
    Category
    Medical Device
    Distribution
    4 states