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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12076–12100 of 39932

  • HighFDA (Devices)·Z-1477-2022·2022-08-03

    Medical Device Kits Recalled for Leaking Isopropyl Alcohol

    Medline Industries is recalling medical device kits nationwide due to leaking isopropyl alcohol bottles. Approximately 28,745 units are affected. Consumers should stop using affected kits and contact the manufacturer.

    Product
    Z-1477-2022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2022·2022-08-03

    Blood Glucose Meter Recalled for Marketing Without FDA Clearance

    Touch US Llc recalled 149 etouchus blood glucose meters (model ETM-G01) because they were marketed without FDA 510(k) clearance or approval. The device was distributed nationwide.

    Product
    etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2022·2022-08-03

    Medline Custom Surgical Kits Recalled for Leaking Isopropyl Alcohol Bottles

    Medline has recalled custom neurosurgical procedure kits nationwide due to leaking bottles of isopropyl alcohol. The leakage poses a risk of contamination and chemical exposure during surgical procedures.

    Product
    Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2022·2022-08-03

    Medline Convenience Surgical Kits Recalled Due to Leaking Isopropyl Alcohol

    Medline Convenience surgical kits containing leaking bottles of isopropyl alcohol are being recalled nationwide. The leaking alcohol poses a risk of chemical exposure to healthcare workers and potential contamination of the surgical field.

    Product
    Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2022·2022-08-03

    Medical imaging software may flip left-right brain image orientation

    NordicBrainEX software versions 2.21-2.3.10 may export brain imaging with reversed left-right orientation in certain analysis scenarios, potentially causing diagnostic misinterpretation.

    Product
    nordicBrainEX, software versions 2.21 through 2.3.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2022·2022-08-03

    Medline Medical Convenience Kits Recalled for Leaking Isopropyl Alcohol Bottles

    Medline is recalling medical convenience kits distributed nationwide that contain leaking bottles of isopropyl alcohol. Users should stop using the affected kits.

    Product
    Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2022·2022-08-03

    Dialysis Machine Recalled for Electrical Shock Risk in AquaC UNO H

    The FDA is recalling 277 Fresenius AquaC UNO H dialysis machines due to misaligned internal ethernet cables that could expose the external port to electrical current, creating a shock risk for service technicians.

    Product
    AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2022·2022-08-03

    HammerTube 2.75mm Implant Recalled for Missing Titanium Plasma Coating

    Paragon 28 recalls HammerTube implants missing their titanium plasma coating. Affected implants were distributed to facilities in Alabama, California, Georgia, Illinois, and Kentucky.

    Product
    HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2022·2022-08-03

    TruClear Hysteroscopic Tissue Removal Control Unit Electrical Failure

    Covidien is recalling 33 TruClear Hysteroscopic Tissue Removal System Control Units due to electrical component failure causing loss of device function during surgery. The affected units were distributed to multiple U.S. states and foreign countries.

    Product
    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
    Category
    Medical Device
    Distribution
    15 states
  • 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