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)

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23801–23825 of 40299

  • HighFDA (Devices)·Z-1876-2018·2018-05-23

    Nipro Blood Tubing Set Recalled Due to Potential Heparin Line Occlusion

    Nipro Medical Corporation is recalling specific blood tubing sets used in hemodialysis because the heparin line may be occluded.

    Product
    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1806-2018·2018-05-23

    Zimmer Biomet Recalls Persona Stemmed Tibial Provisional Instruments

    Zimmer Biomet is recalling 842 Persona Stemmed Tibial Provisional instruments due to potential raw material cracks that could compromise cleanliness.

    Product
    Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2018·2018-05-23

    Tosoh Bioscience Recalls HbA1c Control Due to Erroneous Results

    Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c Control because the product may generate erroneously elevated or decreased HbA1c patient results.

    Product
    Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2018·2018-05-23

    Tosoh HbA1c Calibrator Recalled for Potential Inaccurate Patient Results

    Tosoh Bioscience Inc is recalling HbA1c Calibrators because they may cause erroneous patient test results.

    Product
    Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Lubrication Defect

    Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may cause staple line failure, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2018·2018-05-23

    Zimmer Biomet Recalls Persona Cemented Tibial Plate Due to Cracks

    Zimmer Biomet is recalling 842 Persona Cemented Tibial Plate units due to potential cracks in the raw material that could compromise product cleanliness.

    Product
    Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2018·2018-05-23

    Medtronic Endo GIA Stapler Recall Due to Missing Sled Component

    Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2018·2018-05-23

    Medtronic Endo GIA Universal Stapler Sleeves Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal stapler sleeves and bypass units because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04090 BYPASS AIWA CLINIC Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1890-2018·2018-05-23

    Convatec Esteem Synergy Stomahesive Skin Barrier Recalled for Size Defect

    ConvaTec is recalling 200 boxes of Esteem Synergy Stomahesive skin barriers because the stoma hole is larger than the 22mm size specified on the label.

    Product
    Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1887-2018·2018-05-23

    Ethicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Defect

    Ethicon Endo-Surgery is recalling 1,500 units of 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1891-2018·2018-05-23

    Volcano CORE M2 Vascular System Recalled for Incorrect Resistor

    Volcano Corporation is recalling eight Philips Volcano CORE M2 Vascular Systems because an incorrect resistor causes noise and overly bright images.

    Product
    Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1804-2018·2018-05-23

    Beckman Coulter Recalls MicroScan MICroSTREP Plus Panel Due to QC Failures

    Beckman Coulter is recalling 523 boxes of MicroScan MICroSTREP Plus Panel and associated broth due to quality control testing failures.

    Product
    BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1888-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Lubrication Defect

    Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1885-2018·2018-05-23

    Ethicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Issues

    Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or risk introducing minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1869-2018·2018-05-23

    Rockwell Medical Recalls DriSate Hemodialysis Acid Concentrate Due to Contamination

    Rockwell Medical is recalling DriSate hemodialysis acid concentrate because a subassembly component contained small amounts of sodium bicarbonate from a prior batch.

    Product
    DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1886-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Insufficient Lubrication

    Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2018·2018-05-23

    Bard Peripheral Vascular Seeker Crossing Support Catheter Recalled for Endotoxin Risk

    Bard Peripheral Vascular Inc is recalling 140 units of the Seeker Crossing Support Catheter due to potential bacterial endotoxin on packaging hoops.

    Product
    BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1893-2018·2018-05-23

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Strips Due to Defect

    Beckman Coulter is recalling a subset of iChem VELOCITY Urine Chemistry Strips because an incorrect pad may cause false negative results for leukocytes.

    Product
    iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1875-2018·2018-05-23

    Epic Extremity Plate System Caddy Recalled for Artwork Error

    Epic Extremity, LLC is recalling 9 units of the 10x10 Plate Caddy due to an artwork error that misidentifies a specific plate and screw.

    Product
    Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1874-2018·2018-05-23

    Epic Extremity Plate System Recalled for Packaging Labeling Error

    Epic Extremity, LLC is recalling 6 units of the Epic Extremity Plate System due to a packaging error that misidentifies a specific plate and screw.

    Product
    Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1883-2018·2018-05-23

    Coltene Whaledent Recalls Carbide Burs Due to Incorrect Product Number Labeling

    Coltene Whaledent Inc is recalling 11 packs of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack carbide burs because they are labeled with an incorrect product number.

    Product
    Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1578-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 20 AirLife Resuscitation Broselow Hinkle Kits because the mask component may stick, making it difficult to disconnect from the device.

    Product
    AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1580-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitators Due to Mask Sticking

    Vyaire Medical is recalling 198 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who…
    Category
    Medical Device
    Distribution
    Distributed nationwide