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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10526–10550 of 27441

  • HighFDA (Devices)·Z-0393-2022·2021-12-29

    Stryker DARCO Screw Recall: Incorrect Product in Packaging

    Wright Medical Technology Inc is recalling 250 units of Stryker DARCO Screws (Lot #1643355) because the incorrect product was found in the packaging. Affected units were distributed across multiple U.S. states and countries worldwide.

    Product
    Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0409-2022·2021-12-29

    Malosa Core SMILE Pack Medical Refractive Kit Recalled for Packaging Defect

    Beaver Visitec International is recalling the Malosa Core SMILE Pack 1-Medical Refractive Kit because packaging may contain small holes that compromise sterility. The recall affects 680 units distributed in nine states.

    Product
    Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0407-2022·2021-12-29

    Cataract Surgery Kits Recalled for Compromised Sterile Packaging

    Beaver Visitec is recalling Malosa Core Phaco Pack 1 cataract surgery kits (Part Number: MMK833/2) because packaging may have small holes that compromise product sterility. The recall affects 120 units distributed across nine states.

    Product
    Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0398-2022·2021-12-29

    VirtuTRAX Instrument Navigator devices may not tighten properly

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential mechanical failure that could prevent proper securing of instruments. The device may not tighten onto the instrument as intended.

    Product
    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2022·2021-12-29

    Surgical Corneal Kit Packaging May Compromise Product Sterility

    Beaver Visitec is recalling the Malosa Core Surface Treatment Pack surgical kit because packaging may have holes that compromise sterility during eye procedures.

    Product
    Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0415-2022·2021-12-29

    Surgical Suction Instruments Recalled for Calibration Defect Risk

    Acclarent's TruDi NAV Suction Instruments may be incorrectly calibrated, affecting surgical navigation accuracy. If undetected, the error could cause tissue damage, arterial injury, or nerve damage.

    Product
    TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-0414-2022·2021-12-29

    Skinny Needle with Chiba Tip recalled for debris contamination

    Cook Inc. is recalling Skinny Needles with Chiba Tip due to black debris on internal components that may cause local inflammatory reactions if the product is used.

    Product
    Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2022·2021-12-29

    Medical Refractive Surgery Kit Recalled for Sterility-Compromising Packaging Defects

    Beaver Visitec is recalling 1,170 units of its Malosa Core SMILE Pack 2 surgical refractive kit because packaging may contain small holes that could compromise sterility. Affected units were distributed across nine states.

    Product
    Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0395-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten

    Civco Medical recalls VirtuTRAX Instrument Navigator sensors that may fail to tighten onto instruments during use. No injuries reported.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0337-2022·2021-12-22

    FDA Class I Recall: Cardiosave Rescue Intra-Aortic Balloon Pump Fluid Ingress

    Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system shutdown.

    Product
    Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2022·2021-12-22

    Cardiosave Hybrid IntraAortic Balloon Pump Recall Due to Fluid Ingress Risk

    Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.

    Product
    Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2022·2021-12-22

    Cardinal Health Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals

    Cardinal Health is recalling 364,481 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential for open packaging seals that could compromise sterility. The recalled units were distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2022·2021-12-22

    Orthopedic Femur Plate Recalled for Incorrect MRI Safety Information

    Smith & Nephew is recalling 35 units of EVOS Condylar Medial Distal Femur Plate due to incorrect MRI scanning safety information in the product instructions. The instructions contained erroneous data that could affect patient safety during MRI procedures.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2022·2021-12-22

    Medline Venous Access Pack-LF Recalled for Expired Saline Component

    Medline is recalling Venous Access Pack-LF Convenience Kits because the included saline solution component expired before the kit's labeled expiration date, creating a quality and safety issue.

    Product
    Venous Access Pack-LF Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2022·2021-12-22

    Surgical gowns recalled due to potential compromised sterility from packaging seals

    Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2022·2021-12-22

    Boston Scientific ROTAPRO System Console Recalled for Manufacturing Instruction Deficiency

    Boston Scientific recalled 7 ROTAPRO rotational atherectomy system consoles due to incomplete manufacturing instructions regarding proper handling of the pneumatic kit component upon failure. Affected devices were distributed in six US states and Germany.

    Product
    Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0379-2022·2021-12-22

    Olympus EVIS EXERA II Duodenovideoscope Recalled for Contamination Risk

    Olympus TJF-Q180V duodenovideoscopes with adhesive deterioration or damage may pose infection risk due to endoscope contamination. Approximately 14,447 units are affected.

    Product
    EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2022·2021-12-22

    Cook Flexor Check-Flo Introducer recalled for size mislabeling

    Cook Inc. is recalling the Flexor Check-Flo Introducer due to mislabeled packaging where 6FR devices may be labeled as 7FR or vice versa. This size mislabeling could result in selection of the wrong device size.

    Product
    Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0372-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health is recalling approximately 17,174 Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to potential compromise of packaging seals that could affect product sterility. Units were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2022·2021-12-22

    SmartGown Breathable Surgical Gowns recalled for packaging seal defects

    Cardinal Health is recalling SmartGown Breathable Surgical Gowns because packaging seals may not remain intact, potentially compromising the gowns' sterility. The recall affects 224,312 units distributed in the US and internationally.

    Product
    SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise

    Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2022·2021-12-22

    Neuro Convenience Kit recalled due to expired injectable component

    Medline Industries is recalling the Neuro Convenience Kit because a NaCl injectable component expired in April 2020 while the kit's overall expiration date was later. The expired component may pose a safety risk.

    Product
    Neuro Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0373-2022·2021-12-22

    Cardinal Health Surgical Gowns X-Large Recalled for Packaging Seal Defect

    Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns (X-large, SKU 9040) due to potential compromised packaging seals that could affect sterility. Affected products were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2022·2021-12-22

    Smith & Nephew EVOS Condylar Plate Recalled for Incorrect MRI Instructions

    Smith & Nephew is recalling 41 units of the EVOS Condylar Medial Distal Femur Plate due to erroneous MRI scanning conditions in the instructions for use.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
    Category
    Medical Device
    Distribution
    Distributed nationwide