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.

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11401–11425 of 13717

  • 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-1431-2022·2022-07-27

    BD Connecta Infusion Stopcock Recall Due to Potential Housing Leakage

    BD Connecta Stopcock infusion devices may leak at the housing component, potentially delaying or interrupting treatment and exposing patients to biohazardous material. The recall affects 485,000 units distributed worldwide.

    Product
    BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
    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-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-1409-2022·2022-07-27

    Aesculap Aeos Digital Microscope robotic arm malfunction requires system restart

    Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.

    Product
    Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
    Category
    Medical Device
    Distribution
    1 state
  • 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-1420-2022·2022-07-27

    Ambu VivaSight 2 DLT endobronchial tubes recalled for cuff leak risk

    Ambu Inc. is recalling the VivaSight 2 DLT endobronchial tube system due to reports of cuff leaks or ruptures that could compromise airway security during intubation procedures.

    Product
    Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1416-2022·2022-07-27

    Hill-Rom Centrella Pro+ mattress reduced heat-moisture management performance

    Affected Hill-Rom Centrella Pro+ 36-inch mattresses may have reduced Microclimate Management performance, increasing risk of pressure ulcer development. The failure affects heat and moisture control.

    Product
    Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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-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-1407-2022·2022-07-27

    Nonsterile Components in Medical Convenience Kits Recalled

    ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri because components that were supposed to be sterile were packaged as nonsterile.

    Product
    Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1414-2022·2022-07-27

    Hill-Rom Hospital Mattress Surfaces Recalled for Pressure Ulcer Risk

    Baxter Healthcare is recalling 202 Hill-Rom PRO+ mattress surfaces. The microclimate management feature may malfunction, reducing the product's ability to manage heat and moisture, which increases the risk of patient pressure ulcers.

    Product
    Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
    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-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
  • ModerateFDA (Devices)·Z-1386-2022·2022-07-27

    Stryker Trevo Trak 21 Microcatheter recalled for missing carton product illustration

    Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.

    Product
    Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2022·2022-07-27

    Triton Sponge System Software Instructions Updated for Proper Sponge Handling

    Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.

    Product
    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1404-2022·2022-07-27

    X80 RADiant Photoelectric Therapy System Compatibility Issue

    Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.

    Product
    X80 RADiant Photoelectric Therapy System
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1451-2022·2022-07-27

    LumiraDx SARS-CoV-2 Antibody Quality Control Recalled Due to Unauthorized Modification

    LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.

    Product
    LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1423-2022·2022-07-27

    Soluble Transferrin Receptor Calibrator Recall Due to Lab Errors

    Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.

    Product
    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2022·2022-07-27

    Laboratory Reagent Recalled Due to Inaccurate Calibration Curves

    Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.

    Product
    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1392-2022·2022-07-27

    GreenLight HPSEA Laser Fiber Recall Due to Card Incompatibility Error

    Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.

    Product
    GreenLight HPSEA Laser Fibers, UPN 0010-2092
    Category
    Medical Device
    Distribution
    7 states