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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36901–36925 of 40449

  • HighFDA (Devices)·Z-0520-2014·2013-12-25

    Intuitive Surgical Recalls Mega Needle Drivers for Potential Jaw Detachment

    Intuitive Surgical is recalling Mega Needle Drivers for the da Vinci S and Si systems due to a potential risk of jaw insert detachment.

    Product
    Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2014·2013-12-25

    ASI Medical Recalls SEAC Advanced Dental Systems Due to Air Tank Rupture Risk

    ASI Medical is recalling 337 SEAC Advanced Dental Systems because the miniature plastic air tank can potentially rupture.

    Product
    SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2014·2013-12-25

    Roche MagNA Pure 96 System Recalled for Potential Sample Mismatch

    Roche Diagnostics is recalling 27 MagNA Pure 96 Systems due to a software issue that may cause sample mismatches when importing XML files.

    Product
    MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0550-2014·2013-12-25

    Qualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling six FastPack immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0522-2014·2013-12-25

    Mobility Unlimited Recalls KayserBetten IDA Beds Due to Door Joint Failure

    Mobility Unlimited Inc. is recalling 33 KayserBetten model IDA beds because door joints may loosen or separate, causing doors to drop outward and potentially injure users.

    Product
    KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2014·2013-12-25

    Siemens Recalls Dimension TACR Flex Reagent Cartridges for Stability Issues

    Siemens is recalling Dimension TACR Flex reagent cartridges because reduced stability may cause inaccurate test results for transplant patients.

    Product
    Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2014·2013-12-25

    Intuitive Surgical Recalls Large Needle Drivers Due to Jaw Insert Detachment Risk

    Intuitive Surgical is recalling Large Needle Drivers for the da Vinci S and Si systems because the jaw insert may detach during use.

    Product
    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2014·2013-12-25

    Remel Inc Recalls Streptex Kits Due to Potential False Negative Results

    Remel Inc is recalling 768 Streptex kits because they may produce weak or false negative test results for Streptococcal grouping.

    Product
    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2014·2013-12-25

    Qualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 182 units of the FastPack Total PSA Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0518-2014·2013-12-25

    Kimberly-Clark Epidural Pain Management Trays Recalled for Syringe Defect

    Kimberly-Clark is recalling Single Shot Epidural Pain Management Trays because the included BD LOR Syringes may stall or stick.

    Product
    Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2014·2013-12-25

    Ortho-Clinical Diagnostics Recalls VITROS CA 125 II Calibrators

    Ortho-Clinical Diagnostics is recalling VITROS CA 125 II Calibrators due to a positive shift in patient results.

    Product
    VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2014·2013-12-25

    Integra Epidural Anesthesia Kits Recalled Due to Syringe Plunger Defect

    Integra LifeSciences is recalling specific lots of epidural anesthesia kits because the included BD LOR syringe plunger may stall or stick.

    Product
    Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2014·2013-12-25

    Siemens Dimension Vista Homocysteine Reagent Cartridge Recalled for Erratic Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Homocysteine Flex Reagent Cartridges due to erratic quality control and patient sample recovery.

    Product
    Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid…
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0496-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Shelf-Life Labeling Errors

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates exceeding available shelf-life data.

    Product
    Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2014·2013-12-25

    Arrow International Recalls Nerve Block Catheter Kits Due to Labeling Error

    Arrow International is recalling 121 Continuous Peripheral Nerve Block Catheter Kits because the packaging incorrectly describes the stimulator cable connector.

    Product
    Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0548-2014·2013-12-25

    Qualigen Recalls FastPack Testosterone Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 18 FastPack Testosterone Immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended…
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0505-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0511-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0498-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling certain microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0494-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling Excelsior microcatheters because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0530-2014·2013-12-25

    Remel RapID Yeast Plus System Recalled for Mislabeled Reagents

    Remel Inc is recalling 150 kits of the RapID Yeast Plus System because the labels for Reagent A and Reagent B were reversed.

    Product
    remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0510-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Shelf-Labeling Errors

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates that exceed available shelf-life data.

    Product
    Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide