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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14826–14850 of 27500

  • HighFDA (Devices)·Z-0249-2020·2019-11-06

    Intuitive Surgical Recalls EndoWrist Suction Irrigator Due to Silicone Particle Risk

    Intuitive Surgical is recalling EndoWrist Suction Irrigator instruments because silicone particles may form and be introduced into patients during irrigation.

    Product
    EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0233-2020·2019-11-06

    ConvaTec Recalls Convex Two-Piece Ostomy Skin Barriers Due to Off-Center Stoma Hole

    ConvaTec is recalling convex two-piece ostomy skin barriers manufactured between February 2017 and September 2018 because the stoma hole may be off-center.

    Product
    Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0255-2020·2019-11-06

    Centurion Medical Recalls Port Access Kits Due to Needle Issue

    Centurion Medical Products Corporation is recalling 11,260 Port Access Kits distributed in Illinois. The recall was initiated by the supplier due to an issue with GRIPPER Needles.

    Product
    Kit, Port Access Product Code: DYNDC1582A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0227-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Soft Guidewires for Sterility Concerns

    Stryker Neurovascular is recalling 831 units of Synchro2 Soft Guidewires due to a potential loss of sterility. The recall covers units distributed worldwide.

    Product
    Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2020·2019-11-06

    Valeritas Recalls DEMO No Needle Corrugated Cartons Due to Needle Risk

    Valeritas is recalling 21,714 DEMO No Needle Corrugated Cartons because they may contain a needle. The recall covers units distributed nationwide in the U.S.

    Product
    DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2020·2019-11-06

    Pajunk Sprotte Lumbar Puncture Needles Recalled for Sterility Concerns

    Pajunk GmbH is recalling Sprotte Lumbar Puncture Needles because a packaging sealing issue may affect sterility. The recall covers 40,475 devices distributed worldwide.

    Product
    SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2020·2019-11-06

    LivaNova Recalls SORIN Heater-Cooler Systems Due to Disinfectant Failure

    LivaNova USA Inc. is recalling SORIN Heater-Cooler System 3T units because a chemical reaction may render the water preservative ineffective, potentially allowing micro-organism growth.

    Product
    SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: "…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2020·2019-11-06

    BD Vacutainer Eclipse Blood Collection Needles Recalled for Missing Bevel

    Becton Dickinson is recalling specific lots of BD Vacutainer Eclipse Blood Collection Needles because a missing bevel on the non-patient end caused blood leakage.

    Product
    BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0251-2020·2019-11-06

    Eversense CGM Sensors Recalled for Premature Function Failure

    Senseonics is recalling 1,344 Eversense CGM sensors nationwide because they may stop working early due to inadequate hydration of the glucose-sensing surface.

    Product
    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
    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