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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

19226–19250 of 40248

  • ModerateFDA (Devices)·Z-0236-2020·2019-11-06

    Mindray Accutorr 7 Vital Signs Monitor Software Recall

    Mindray is recalling 107 Accutorr 7 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0243-2020·2019-11-06

    A&E Medical Thorecon Plating System Kits Recalled for Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0250-2020·2019-11-06

    Cordis MAXI LD PTA Dilatation Catheter Recalled for Expired Component

    Cordis Corporation is recalling 21 units of MAXI LD PTA Dilatation Catheters because they were manufactured using an expired inner body.

    Product
    Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0218-2020·2019-11-06

    OrthoPediatrics Recalls Child Nail Attachment Bolts Due to Binding Risk

    OrthoPediatrics Corp is recalling 969 Child Nail Attachment Bolts because they may bind with the intramedullary nail, potentially delaying surgical procedures.

    Product
    Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0219-2020·2019-11-06

    OrthoPediatrics Recalls Adolescent Nail Attachment Bolts Due to Binding Risk

    OrthoPediatrics Corp is recalling 969 Adolescent Nail Attachment Bolts because binding between the bolt and nail may delay surgical procedures.

    Product
    Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0253-2020·2019-11-06

    Centurion Medical Recalls Port Full Access Tray Kits in Illinois

    Centurion Medical Products Corporation is recalling 240 Port Full Access Tray kits in Illinois due to a supplier-initiated recall of GRIPPER Needles.

    Product
    Port full Access Tray Product Code: DT19330
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0231-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0225-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0230-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0187-2020·2019-10-30

    Torrent Suite Dx Software Recalled for Incorrect Positive Variant Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.

    Product
    Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0185-2020·2019-10-30

    Life Technologies Recalls Torrent Suite Dx Software for Incorrect Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for specific clinical variants.

    Product
    Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0168-2020·2019-10-30

    Exactech Recalls Ergo 3.2mm K-wires Due to Fracture Risk

    Exactech, Inc. is recalling 158 Ergo 3.2mm K-wires because they may fracture at the threads and remain in the glenoid during shoulder surgery.

    Product
    Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2020·2019-10-30

    GN Otometrics Recalls ICS CHARTR EP 200 Due to Electrical Shock Risk

    GN Otometrics is recalling 3,071 ICS CHARTR EP 200 units because undergrounded electrical surfaces may cause electrical shock to patients or healthcare professionals.

    Product
    The ICS CHARTR EP 200
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0209-2020·2019-10-30

    Candela Surgical Laser Coolant Canisters Recalled for Loose Bushing

    Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may separate during use in specific legacy devices.

    Product
    Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0182-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects

    Andover Healthcare Inc. is recalling 1,759 cases of sterile Co-Flex LF2 wound dressings because of incomplete packaging seals, which may compromise sterility.

    Product
    Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2020·2019-10-30

    Candela HFC-134a Coolant Canisters Recalled for Loose Neck Bushing

    Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may become loose and separate from the canister body during use.

    Product
    Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0165-2020·2019-10-30

    Rifton TRAM Low Base Lift Device Recalled for Buckle Fatigue Failure

    Community Products is recalling 1,079 Rifton TRAM Low Base powered lift devices because a design change makes the latch springs susceptible to fatigue failure.

    Product
    Rifton TRAM Low Base, SKU K320, powered lift device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2020·2019-10-30

    GE Healthcare ApexPro Telemetry Server System Recall for Alarm Failure

    GE Healthcare is recalling ApexPro Telemetry Server Systems because they may fail to provide visual or audible alarms for ECG arrhythmias, lead failures, or pulse oximetry issues.

    Product
    ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2020·2019-10-30

    Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

    Smiths Medical ASD Inc. is recalling GRIPPER Needles because some may be occluded or blocked, posing a risk to patients.

    Product
    GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2020·2019-10-30

    Abbott Recalls Emerald Diluent Tubing Due to Cloudiness and Film

    Abbott Laboratories is recalling 22 CELL-DYN Emerald analyzers with diluent tubing that appears cloudy or has a film, which may cause falsely elevated platelet results.

    Product
    Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0210-2020·2019-10-30

    Beckman Coulter Lipase Recalled Due to Acetaminophen Interference

    Beckman Coulter is recalling Lipase assays because acetaminophen metabolites cause negative interference in overdose patients.

    Product
    Beckman Coulter Lipase, REF OSR6130 and OSR6230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2020·2019-10-30

    OMNI Hip System Femoral Component Recalled for Missing Porous Coating

    OMNIlife science Inc. is recalling three OMNI Hip System femoral components because they are missing the required porous coating.

    Product
    OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0176-2020·2019-10-30

    Brainlab Patient Data Manager Software Recall for Data Export Errors

    Brainlab is recalling Patient Data Manager software versions 2.1.1 through 2.5.1 because segmentation shifts may not be reflected in DICOM exports.

    Product
    Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA…
    Category
    Medical Device
    Distribution
    0 states