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 deaths or serious injuries are reported, 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.

Filters

Agency

Category

Minimum severity

Clear filters

11451–11475 of 13803

  • 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
  • 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-1408-2022·2022-07-27

    Nonsterile convenience kit recall due to sterile component mislabeling

    ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.

    Product
    Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1427-2022·2022-07-27

    GE Anesthesia Systems Base Cracking and Fall Hazard Recalled

    GE Healthcare anesthesia systems may develop cracks in the base, potentially causing the device to tip and fall. The FDA recalled 667 units distributed across multiple U.S. states and countries.

    Product
    GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1429-2022·2022-07-27

    Spinal fixation removal key fracture risk under misuse conditions

    The ENNOVATE MIS removal key used in spinal fixation systems may fracture if the 90-degree angle is not maintained during use. A product redesign is underway.

    Product
    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1434-2022·2022-07-27

    BD Connecta Stopcock recalled for potential housing leakage risk

    Becton Dickinson is recalling BD Connecta Stopcocks due to potential leakage at the housing component. The defect may interrupt treatment and expose patients to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1410-2022·2022-07-27

    Modulift VBR Surgical Screwdriver Fails Due to Tip Deformation

    Aesculap is recalling the Modulift VBR 4MM set screwdriver due to tip deformation during surgical engagement with implants. The device is distributed in CA, FL, GA, IL, OH, and MI.

    Product
    MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1439-2022·2022-07-27

    BD Connecta Plus3 infusion connector recalled for potential stopcock leakage

    Becton Dickinson is recalling BD Connecta Plus3 White Blend infusion connectors (Lot 1127328) due to potential stopcock leakage. The defect may interrupt treatment, expose patients to biohazardous material, or cause under-infusion.

    Product
    BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2022·2022-07-27

    Aesculap Sterile Disposable Fleece Drape Recalled Due to Packaging Seal Integrity Issue

    Aesculap recalls 4500 sterile disposable fleece drapes (Product code GA414) due to unvalidated packaging seal integrity, which may compromise sterility assurance. Distribution occurred in 14 U.S. states.

    Product
    Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1452-2022·2022-07-27

    SurgiCount+ System software error bypasses sponge tracking alerts

    A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.

    Product
    SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1425-2022·2022-07-27

    Sensis diagnostic tool software may fail to display vital signs

    Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.

    Product
    Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2022·2022-07-27

    Radiation treatment planning software fails to propagate treatment course data

    RayStation 9B SP1 radiation treatment planning software has an issue where treatment course information may not be propagated to other systems in some workflows. This could potentially affect treatment planning accuracy.

    Product
    RayStation 9B SP1. For radiation treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2022·2022-07-27

    BD Connecta White 360 Infusion Connector Recalled for Potential Leakage

    Becton Dickinson recalls BD Connecta White 360 infusion connectors for potential leakage at the stopcock housing. The defect may interrupt treatment and expose patients to biohazardous materials.

    Product
    BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2022·2022-07-27

    Spinal Fixation Device Removal Key Recalled Due to Potential Fracture Risk

    Aesculap Implant Systems recalls ENNOVATE MIS REMOVALKEY SHORT due to fracture risk if removal key is not used at 90-degree angle. Affected units distributed in CA, CO, IL, MI, OH, and TX.

    Product
    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1433-2022·2022-07-27

    BD Connecta Stopcock Recalled for Potential Housing Leakage

    Becton Dickinson is recalling approximately 1.96 million BD Connecta Stopcock devices due to potential leakage at the housing component, which could interrupt treatment and expose patients to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1406-2022·2022-07-27

    Spinal Surgery Instrument Recall: LEFT CORONAL BENDER May Deform Implants

    Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.

    Product
    LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1424-2022·2022-07-27

    Randox Cholesterol In Vitro Diagnostic Kits Fail Stated Performance Specifications

    Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.

    Product
    Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2022·2022-07-27

    Hobbs Medical Polypectomy Snare May Fail to Close Properly

    Hobbs Medical Polypectomy Snares (Catalog No. 7202) may accordion at the proximal end, preventing full closure and potentially causing injury. Specific lots distributed to medical facilities in NC, TX, WA, and Canada are affected.

    Product
    Hobbs Medical Polypectomy Snare, Catalog No. 7202
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1435-2022·2022-07-27

    BD Connecta Stopcock Without Extension Tube Recalled for Potential Leakage Risk

    Becton Dickinson & Company is recalling BD Connecta Stopcock units worldwide due to a potential housing leakage defect that could interrupt treatment or cause exposure to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2022·2022-07-27

    Sensis Vibe Combo Device Recalled for Software Communication Failure

    The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.

    Product
    Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2022·2022-07-27

    Surgical knee implant instrument key may become nonfunctional during assembly

    Aesculap is recalling the ENDURO SPECIAL KEY TIB.LOCK.RING (product code NP462R) used in knee replacement surgery because the key pins may be damaged during assembly, causing the instrument to become nonfunctional.

    Product
    ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2022·2022-07-27

    Spinal Fusion Implant Cross Connectors Recalled for Insufficient Clamping Force

    Aesculap is recalling its S4 Cervical Cross Connector used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to move on the rods or shed particles.

    Product
    AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2022·2022-07-27

    Surgical Coronal Bender May Deform Spinal Implants During Surgery

    Aesculap's coronal rod benders used in spinal surgery may deform implants during use. A Class II recall affects 2 units in Colorado.

    Product
    RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
    Category
    Medical Device
    Distribution
    1 state