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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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Minimum severity

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

Clear filters

31951–31975 of 40449

  • SevereFDA (Devices)·Z-2750-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Maryland Dissector Instruments

    Intuitive Surgical is recalling 8,217 Maryland Dissector instruments used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2752-2015·2015-09-16

    Intuitive Surgical Recalls Cadiere Forceps for da Vinci Si System

    Intuitive Surgical is recalling Cadiere Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.

    Product
    Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2742-2015·2015-09-16

    Terumo CDI 500 Blood Parameter Monitoring System Recalled for Inaccurate Readings

    Terumo is recalling 4,638 CDI 500 Blood Parameter Monitoring Systems worldwide due to inaccurate readings of vital blood parameters following a software upgrade to version 1.69.

    Product
    CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2746-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Acetabular Cup Recalled

    Smith & Nephew is recalling specific Birmingham Hip Resurfacing Acetabular Cups because the system's revision rates were higher than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2015·2015-09-16

    Medtronic Hemocor Hemoconcentrators Recalled for Low Ultrafiltration Performance

    Medtronic Perfusion Systems is recalling Hemocor Hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2015·2015-09-16

    Intuitive Surgical Recalls Fenestrated Bipolar Forceps for da Vinci System

    Intuitive Surgical is recalling 21,684 Fenestrated Bipolar Forceps used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2753-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Needle Drivers

    Intuitive Surgical is recalling 89 da Vinci Si Single-Site Needle Drivers because the jaws may become fixed in a closed position.

    Product
    Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2015·2015-09-16

    Intuitive Surgical Recalls Curved Needle Drivers for da Vinci System

    Intuitive Surgical is recalling 3,698 Curved Needle Drivers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2751-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Clip Appliers

    Intuitive Surgical is recalling 17,617 da Vinci Si Single-Site Clip Appliers because the jaws may become fixed in a closed position during use.

    Product
    Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Femoral Head Recall

    Smith & Nephew is recalling 5,987 units of the Birmingham Hip Resurfacing Femoral Head due to revision rates higher than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2741-2015·2015-09-16

    Siemens Recalls Dimension CREA Tests for Falsely Depressed Results

    Siemens Healthcare Diagnostics is recalling Dimension CREA and Dimension Vista CREA tests because they may produce falsely depressed creatinine results in the presence of hemolysis.

    Product
    Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2747-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Dysplasia Cup Recall

    Smith & Nephew is recalling Birmingham Hip Resurfacing Dysplasia Cups because the system showed higher revision rates than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2738-2015·2015-09-16

    Trilliant Gridlock Screw Driver Bits Recalled for Out-of-Specification Dimensions

    Trilliant Surgical Ltd. is recalling 108 units of Gridlock Screw Driver Bits because they are out of specification, which may cause screw heads to strip during surgery.

    Product
    2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2748-2015·2015-09-16

    Elcam Medical stopcock recall due to punctured blister packages

    Elcam Medical is recalling stopcocks because punctured blister packages were found during manufacturing, creating a potential for device contamination.

    Product
    Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2755-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Crocodile Graspers

    Intuitive Surgical is recalling 15,834 da Vinci Si Single-Site Crocodile Graspers because the instrument jaws may become fixed in a closed position.

    Product
    Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2756-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Maryland Bipolar Forceps

    Intuitive Surgical is recalling 13,644 Maryland Bipolar Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.

    Product
    Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2749-2015·2015-09-16

    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN Recalled for Punctured Packaging

    Elcam Medical is recalling MANI 3G Plate BLS RAD B.BRAUN manifolds because punctured blister packages were detected during manufacturing, creating a potential for device contamination.

    Product
    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2737-2015·2015-09-16

    Mindray DPM 7 Patient Monitors Recalled for Black Screen Display

    Mindray is recalling 13 DPM 7 patient monitors because they may display a black screen, potentially preventing the display of patient data.

    Product
    Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2740-2015·2015-09-16

    DermaPen Pro Micro Needling System Recalled for Lack of FDA Clearance

    Derma Pen, LLC is recalling DermaPen Pro Micro Needling Systems because the devices were distributed without FDA clearance or approval.

    Product
    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2744-2015·2015-09-16

    Biomet C-Tek Maxan Anterior Cervical Plate System Mislabeled Recall

    Biomet Spine is recalling 7 parts of the C-Tek Maxan Anterior Cervical Plate System because some units were mislabeled with an incorrect part number.

    Product
    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2739-2015·2015-09-16

    Siemens ADVIA Centaur Folate Diluent Recalled for Low Recovery Results

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate Ascorbic Acid Diluent because it causes low red blood cell control recoveries and low patient sample results.

    Product
    ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2736-2015·2015-09-16

    Medtronic Perfusion Tubing Packs Recalled for Low Ultrafiltration Performance

    Medtronic is recalling specific perfusion tubing packs and hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2759-2015·2015-09-16

    Biomet Spine Lineum OCC Starter Flexible Instruments Recalled for Design Control Issues

    Biomet Spine is recalling Lineum OCC Starter Flexible instruments because they were distributed before design control activities were completed.

    Product
    Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2560-2015·2015-09-09

    Customed Arthroscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 45 Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2558-2015·2015-09-09

    Customed Cysto TUR Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 290 packs of Cysto TUR Pack due to inadequate validation of sterilization processes and package integrity.

    Product
    CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state