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

11401–11425 of 13717

  • HighFDA (Devices)·Z-1436-2022·2022-07-27

    BD Connecta 3-Way Stopcocks Recalled Due to Potential Leakage

    Becton Dickinson recalls BD Connecta 3-Way Stopcocks due to potential leakage at the housing that may delay treatment and expose patients to biohazardous material.

    Product
    BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
    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-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-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-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-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-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-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-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-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-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-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-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-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-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-1447-2022·2022-07-27

    Aesculap S4 Cervical Cross Connector Recalled Due to Clamping Force Defect

    Aesculap Implant Systems is recalling the S4 Cervical Cross Connector L 33-42mm due to insufficient clamping force that may cause connector movement or microparticle abrasion in spinal fusion implants.

    Product
    AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
    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-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-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
  • 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-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-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-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