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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11551–11575 of 13717

  • HighFDA (Devices)·Z-1261-2022·2022-06-22

    FDA Recalls Axium Detachable Coil Systems for Incorrect Labeling

    Micro Therapeutics is recalling Axium Detachable Coil Systems due to incorrect size and configuration labeling. The 96 affected units were distributed to China and the Republic of Korea.

    Product
    AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1268-2022·2022-06-22

    Medtronic Crome and Cobalt Cardiac Defibrillators Recalled Due to Telemetry Error

    Medtronic recalls 3,944 Crome and Cobalt ICDs and CRT-Ds due to a potential telemetry error affecting device communication with external monitors.

    Product
    Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2022·2022-06-22

    Olympus endoscope diopter ring adhesive failure may impair vision

    Olympus endoscopes with defective diopter ring adhesive may cause vision loss and, in rare cases, urinary tract perforation.

    Product
    Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1258-2022·2022-06-22

    Tandem t:slim X2 Insulin Pump Battery Display May Cause Insulin Delivery Failure

    Tandem t:slim X2 insulin pumps may display inaccurate battery levels, risking insulin delivery failure if the battery depletes unexpectedly. Users should maintain battery above 25% to prevent unintended insulin cessation.

    Product
    t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1270-2022·2022-06-22

    Philips OmniWire guide wire recalled for potential sterilization failure

    Volcano Corp is recalling 11 Philips OmniWire Pressure guide wires distributed in Washington, Wisconsin, and Canada due to a potential failed sterilization process.

    Product
    Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1227-2022·2022-06-15

    Ventilator Backup Battery Failure Recalled by GE Healthcare Worldwide

    GE Healthcare is recalling backup batteries for ventilators used in critical care. The batteries may not provide sufficient backup power when disconnected from AC, potentially causing unexpected device shutdown.

    Product
    Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1226-2022·2022-06-15

    GE Healthcare Ventilators Recalled for Insufficient Battery Backup Power

    GE Healthcare is recalling multiple ventilator models due to insufficient battery backup power. The affected units may shut down prematurely when not connected to AC power.

    Product
    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1207-2022·2022-06-15

    HeartWare HVAD Pump Implant Kit recalled for welding defect risk

    Medtronic is recalling HeartWare HVAD Pump Implant Kit units due to a welding defect in the center post cap that can lead to pump malfunction and affect blood flow.

    Product
    HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2022·2022-06-15

    Siemens Artis Icono Angiography Systems Pose Electric Shock Risk

    Siemens Artis icono angiography systems may pose electric shock risk if protective grounding is interrupted. Affected units sold nationwide; users should verify equipment grounding integrity.

    Product
    Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2022·2022-06-15

    FDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination

    Helena Laboratories is recalling the V8 Immunodisplacement Kit (51 units) due to microbial contamination that interferes with test interpretation. The FDA Class II recall affects kits distributed in the U.S. and internationally.

    Product
    V8 Immunodisplacement Kit REF 1803
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1251-2022·2022-06-15

    Medical Device Test Strip Recall: Potential False Negatives for Respiratory Pathogens

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 test strips may produce false negative results for low viral loads, delaying diagnosis and treatment. The recall affects 459 U.S. kits and 1,626 international kits.

    Product
    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1256-2022·2022-06-15

    Reliance Synergy Washer/Disinfector fire hazard due to electrical contactor malfunction

    Steris Corporation is recalling Reliance Synergy Washer/Disinfector units due to a malfunctioning electrical contactor that can cause heating elements to overheat, creating a fire risk. Affected units may generate smoke and fire in the drying chamber.

    Product
    Reliance Synergy Washer/Disinfector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1239-2022·2022-06-15

    Oakworks Emergency Field Bed Recalled for Incorrect Weight Capacity Label

    Oakworks has recalled 109 units of its Emergency Field Bed due to an incorrect weight capacity label. The label states 500 lbs, but the bed's actual weight limit is 400 lbs.

    Product
    Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1247-2022·2022-06-15

    GMK Sphere CR Size 1 Instrument Set Assembly Defect Recall

    Medacta Usa Inc recalls GMK Sphere CR Insert Instrument Set Size 1 due to component assembly error: Size 2 trial baseplates were assembled with Size 1 instrument sets, potentially affecting surgical function.

    Product
    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1252-2022·2022-06-15

    Atellica IM 1300 Analyzers Incompatible with Software Can Produce Erroneous Thyroid Results

    Siemens is recalling 1,566 Atellica IM 1300 Analyzers distributed worldwide because certain lots are incompatible with Test Definition version 1.4 and may generate incorrect total T3 thyroid test results.

    Product
    Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2022·2022-06-15

    Getinge CM320-2 Surgical Instrument Washer Disinfector Recalled for Incomplete Installation Verification

    Getinge recalls its CM320-2 washer disinfector due to unverified or incomplete installation, which could cause skin burns, electric shock, smoke inhalation, or crush injuries. Four units were distributed across seven US states.

    Product
    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2022·2022-06-15

    Surgical needle electrode tip detachment risk during gastroenterology procedures

    ROi CPS LLC is recalling a sterile surgical needle used in gastroenterology bypass procedures because the electrode tip may detach during use. The recall affects 125 units distributed in North Carolina.

    Product
    Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1243-2022·2022-06-15

    Siemens Sensis Diagnostic Computer: Software Issues May Prevent Treatment Continuation

    Siemens has identified three potential software issues in Sensis programmable diagnostic computers. The issues may prevent treatment from continuing on the device, requiring patients to switch to alternate systems.

    Product
    Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2022·2022-06-15

    Cook Nester Embolization Microcoil recalled for unintended cannula defect

    Cook Incorporated recalls Nester Embolization Microcoil devices whose loading cartridges may contain an unintended stainless-steel cannula. Affected devices were distributed domestically and worldwide.

    Product
    Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2022·2022-06-15

    Hilal Embolization Microcoils Recalled for Unintended Stainless-Steel Cannula

    Cook Incorporated is recalling Hilal Embolization Microcoils because their loading cartridges may contain an unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide and internationally.

    Product
    Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2022·2022-06-15

    Siemens Atellica IM 1600 Analyzer Recalled for Potential Erroneous Test Results

    Siemens recalled 2,321 Atellica IM 1600 Analyzers due to incompatibility with Test Definition Version 1.4, which may produce erroneous total T3 test results. Worldwide distribution affected.

    Product
    Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2022·2022-06-15

    Triathlon Tritanium Tibial Components Recalled for Size-Packaging Mismatch

    Howmedica Osteonics is recalling specific lots of Triathlon Tritanium Tibial Components (knee implants) due to a potential mismatch between package labeling and the actual component size contained inside.

    Product
    Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2022·2022-06-15

    Medical imaging software distance and area measurements may display inaccurately

    Centricity Enterprise Web medical imaging software may display inaccurate distance and area measurements when processing magnified or scaled images. The software is distributed to healthcare facilities worldwide.

    Product
    Centricity Enterprise Web
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2022·2022-06-15

    DJO EMPOWR 3D Knee Tibial Insert Mispackaged—Risk of Wrong Implant

    Encore Medical is recalling DJO EMPOWR 3D Knee tibial inserts because packages may contain a mismatched left-size component instead of the correct right-size implant. If implanted, the wrong component could leave debris in the joint.

    Product
    DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
    Category
    Medical Device
    Distribution
    Distributed nationwide