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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12126–12150 of 40095

  • HighFDA (Devices)·Z-1479-2022·2022-08-03

    Revogene diagnostic test instrument recalled for burn risk from cooling failure

    Meridian Bioscience recalled 459 Revogene diagnostic instruments due to a cooling protection failure that may expose users to heated components, risking minor burn injuries.

    Product
    Revogene, Catalog no. 610210. IVD test instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1460-2022·2022-08-03

    Da Vinci Surgical Clip Appliers Recalled for Potential Unexpected Motion

    Intuitive Surgical is recalling three models of Da Vinci clip appliers due to potential unexpected motion from partial instrument disengagement. Approximately 90,628 units have been distributed worldwide.

    Product
    Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2022·2022-08-03

    X-Stream Irrigation System recalled due to potential fire hazard

    Davol, Inc. is recalling the X-Stream Irrigation System due to a potential fire hazard. The device may cause a fire during use, creating a safety risk.

    Product
    X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2022·2022-08-03

    Alinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results

    Abbott Laboratories is recalling Alinity c Hemoglobin Reagent Kits (lots 59801UQ04 and 60763UQ09) due to a potential for falsely elevated hemoglobin A1c test results when used with ARCHITECT and Alinity c analyzers.

    Product
    REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1478-2022·2022-08-03

    Stryker Craniotomy Router May Break and Leave Metal Fragments

    Stryker 2.3mm Tapered Router (craniotomy instrument) may break due to undersized core, leaving metal fragments in the surgical site. This risks damage to critical brain structures or need for additional surgery.

    Product
    Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2022·2022-08-03

    Medline medical device kits recalled for leaking isopropyl alcohol bottles

    Medline Industries is recalling medical convenience kits containing leaking bottles of isopropyl alcohol due to chemical exposure risk. The recall affects 288 units distributed nationwide.

    Product
    Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2022·2022-08-03

    Medline LAP CHOLE convenience kits recalled for leaking isopropyl alcohol

    Medline is recalling LAP CHOLE convenience kits due to leaking bottles of isopropyl alcohol. The affected kits were distributed nationwide.

    Product
    Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2022·2022-08-03

    AquaC UNO H Dialysis Machine Recalled Due to Electrical Shock Risk

    Fresenius is recalling 318 AquaC UNO H dialysis machines nationwide due to a potential electrical shock hazard affecting service technicians and operators. An internal ethernet cable may become misaligned, damaging insulation and creating an electrical hazard when the external port is touched.

    Product
    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1458-2022·2022-08-03

    Paragon 28 Gorilla Plating System Drill Recalled for Incorrect Packaging Label

    Paragon 28, Inc. has recalled Baby Gorilla/Gorilla Plating System drills (Ref: P99-100-2816) because the drill packaging may contain incorrect part numbers.

    Product
    Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1465-2022·2022-08-03

    ZEISS Axio Observer 5 Microscope Recalled for Incorrect Device Identification Label

    Zeiss is recalling ZEISS Axio Observer 5 microscopes due to an incorrect Unique Device Identification (UDI) label installed on some units. The labeling discrepancy affects device tracking and identification.

    Product
    ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1389-2022·2022-07-27

    GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal

    GE Healthcare anesthesia systems may have reversed oxygen and air transducer connections, potentially affecting proper gas delivery. 5,372 devices worldwide are affected.

    Product
    GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2022·2022-07-27

    Hill-Rom Mattress Microclimate Feature Failure Increases Pressure Ulcer Risk

    Certain Hill-Rom PRO+ MRS mattresses may have a Microclimate Management feature failure that increases patient pressure ulcer risk. Affected units were distributed to 25+ U.S. states and Canada.

    Product
    Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1412-2022·2022-07-27

    Hill-Rom PRO+ Mattress Microclimate Management Failure Increases Pressure Ulcer Risk

    Baxter Healthcare is recalling 404 Hill-Rom PRO+ 36" mattresses due to performance degradation in their heat and moisture management feature. This failure increases the risk of pressure ulcer development in patients.

    Product
    Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2022·2022-07-27

    SIGNA Premier MRI scanner recalled for elevated acoustic noise hazard

    GE Healthcare's SIGNA Premier MRI scanner is being recalled because under rare conditions, the gradient coils can produce elevated acoustic noise that could potentially cause hearing loss with prolonged exposure.

    Product
    SIGNA Premier magnetic resonance scanner, model 5748519.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2022·2022-07-27

    Spinal fusion cross connector recalled for insufficient clamping force

    Aesculap is recalling AESCULAP S4 Cervical Cross Connectors used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to loosen or shift on the spinal rods.

    Product
    AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2022·2022-07-27

    BD Connecta Plus1 360 Infusion Connector: Potential Housing Leakage

    Becton Dickinson is recalling certain BD Connecta Plus1 360 Blue Blend infusion connectors due to potential leakage at the housing stopcock that could interrupt treatment and expose patients to contamination and biohazardous material.

    Product
    BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2022·2022-07-27

    Orthopedic Surgical Guide with Defective Spring Subject to Corrosion

    DePuy Orthopaedics is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide due to a manufacturing defect. A galvanized steel spring was used instead of stainless steel, which may cause corrosion and surgical complications.

    Product
    ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2022·2022-07-27

    BD Connecta Stopcock Recalled for Potential Housing Leakage

    Becton Dickinson is recalling its BD Connecta Stopcock due to potential leakage at the housing component, which may interrupt treatment and cause exposure to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2022·2022-07-27

    LumiraDx SARS-CoV-2 Antibody Test Strip Modified Outside Approved Scope

    LumiraDx recalled SARS-CoV-2 Antibody Test Strips after discovering modifications were made outside the FDA-approved Emergency Use Authorization scope. The recall affects 635 units in 13 states.

    Product
    LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1441-2022·2022-07-27

    Nexiva IV Catheter Stopcock May Leak During Infusion

    Becton Dickinson is recalling specific lots of Nexiva IV catheters because the stopcock housing may leak, potentially interrupting treatment and exposing patients to infusate and biohazardous material.

    Product
    Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2022·2022-07-27

    Cervical spinal implant connectors may have insufficient clamping force

    Aesculap S4 Cervical Cross Connectors used in spinal fusion surgery may have insufficient clamping force, potentially causing movement of the connectors on the rods or wear debris.

    Product
    AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2022·2022-07-27

    SX-One MicroKnife Recalled for Potential Dull Blade Defect

    Sonex Health LLC is recalling approximately 3,752 SX-One MicroKnife surgical instruments nationwide due to potential blade dulling that may compromise proper function.

    Product
    SX-One MicroKnife
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2022·2022-07-27

    Medical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error

    CooperSurgical recalls its LifeGlobal Fast Freeze Thawing Kit due to a Spanish instruction translation error that specifies 5 minutes instead of 5 seconds for blastocyte air thawing, affecting 403 units.

    Product
    LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1440-2022·2022-07-27

    Nexiva Infusion Device Stopcock May Leak During Treatment

    Becton Dickinson is recalling Nexiva infusion devices with pink stopcock components due to potential leakage at the housing that could interrupt treatment or expose patients to infusate and biohazardous material.

    Product
    Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2022·2022-07-27

    Surgical Seal Packaging May Compromise Sterility in Laparoscopic Devices

    Surgical Innovations Ltd recalls YelloPort Elite Universal Seals due to potential holes in packaging that may affect product sterility. Worldwide distribution affected.

    Product
    YelloPort Elite Universal Seal. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide