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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14576–14600 of 27500

  • HighFDA (Devices)·Z-0733-2020·2020-01-01

    Medtronic Lamicel Cervical Dilators Recalled for Sterilization Defect

    Medtronic Xomed is recalling Lamicel 20PK 3MM INTL Cervical Dilators because the sterilization dose did not meet the required Sterility Assurance Level.

    Product
    Lamicel 20PK 3MM INTL Cervical dilator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0020-2020·2020-01-01

    Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure

    Galemed Corporation is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0719-2020·2020-01-01

    3M Recalls Durapore Advanced Surgical Tape Due to Bond Failure Risk

    3M is recalling Durapore Advanced Surgical Tape because long-term exposure to high moisture may cause bond failure and fiber fraying, posing a risk of accidental ingestion or aspiration.

    Product
    3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0715-2020·2019-12-25

    Arrow Berman Angiographic Catheter Recalled for Potential Leak

    Arrow International Inc. is recalling 71 units of Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.

    Product
    Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2020·2019-12-25

    Arrow Berman Angiographic Catheter Recalled for Potential Balloon Leak

    Arrow International Inc is recalling specific Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.

    Product
    Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2020·2019-12-25

    Southwest Technologies Recalls Mold-Contaminated Elasto-Gel Wound Dressings

    Southwest Technologies Inc is recalling Elasto-Gel Absorbent Wound Dressings due to potential mold contamination. The affected sterile dressings were distributed to nine states.

    Product
    Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0679-2020·2019-12-25

    Roche Homocysteine Test Recalled for Calibration Failures and Quality Control Issues

    Roche Diagnostics is recalling 82 units of Homocysteine tests due to calibration failures and quality control recovery issues on cobas c 701 and 702 modules.

    Product
    Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2020·2019-12-25

    GE Healthcare Recalls Aestiva MRI Systems Due to Cybersecurity Vulnerability

    GE Healthcare is recalling 502 Aestiva MRI systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0695-2020·2019-12-25

    Siemens Artis zee X-Ray System Recalled for Collision Sensor Defect

    Siemens is recalling three Artis zee Interventional Fluoroscopic X-Ray Systems because a collision sensor defect may block tabletop movement, potentially delaying or interrupting procedures.

    Product
    Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0712-2020·2019-12-25

    Angiodynamics Recalls 60 Micro-PSD HDR Radiation Therapy Sensors

    Angiodynamics, Inc. is recalling 60 Micro-PSD HDR sensors because they may provide readings outside the expected accuracy range.

    Product
    MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2020·2019-12-25

    Angiodynamics Recalls OARtrac PLUS Clinical Detector Units Due to Accuracy Issues

    Angiodynamics, Inc. is recalling four OARtrac PLUS Clinical Detector Units because they may produce readings outside the expected accuracy range.

    Product
    OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2020·2019-12-25

    Medtronic Percutaneous Pin Adapter Recall for Potential Rotation

    Medtronic is recalling 1,297 percutaneous pin adapters because they may rotate after surgical placement and fail to return to their original position.

    Product
    Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2020·2019-12-25

    VisuMax Software Recall for Incorrect Corneal Cut Type During Suction Loss

    Carl Zeiss Meditec is recalling VisuMax software version 2.10.13 because a defect may cause a cap cut instead of a flap cut if suction is lost during treatment.

    Product
    VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2020·2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, risking needle stick injuries and sterility compromise.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2020·2019-12-25

    DeRoyal Warrior Recovery Knee Brace Recalled for Hinge Breakage Risk

    DeRoyal Industries is recalling Warrior Recovery Knee Braces because the hinge may break, causing the brace to come apart.

    Product
    DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2020·2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, exposing needles and compromising sterility.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2020·2019-12-25

    GE Healthcare Recalls Aespire and Aestiva Anesthesia Systems for Cybersecurity Vulnerability

    GE Healthcare is recalling Aespire and Aestiva anesthesia systems due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0696-2020·2019-12-25

    Smith & Nephew Recalls PROFIX Mallets Due to Tip Detachment Risk

    Smith & Nephew is recalling 1,371 PROFIX Mallets because the poly tip may detach during surgery, potentially releasing particles into the surgical field.

    Product
    smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2020·2019-12-25

    Bio-Signal Group Recalls HydroDot Wave Prep Cups Due to B. cepacia Contamination

    Bio-Signal Group Corp. is recalling HydroDot Wave Prep single-use cups due to potential contamination with Burkholderia cepacia. The product is distributed in six US states.

    Product
    HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2020·2019-12-25

    GE Healthcare Recalls Aestiva 7900 Anesthesia Systems for Cybersecurity Vulnerability

    GE Healthcare is recalling 7,168 Aestiva 7900 anesthesia systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-9030-000 k) 1006-9032-000 l) 1006-9022-000 m) To be provided n)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0117-2020·2019-12-25

    GE Healthcare Recalls Aestiva 7100 Anesthesia Systems Due to Cybersecurity Vulnerability

    GE Healthcare is recalling 473 Aestiva 7100 anesthesia systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-015180 10. 1006-9320-000-010369 11. 1006-9321-000-019486 12.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0690-2020·2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, exposing needles and compromising sterility.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2020·2019-12-25

    NxStage Low Volume Cartridge Recalled for Hemodialysis Risk

    NxStage Medical is recalling Low Volume Cartridge IFUs due to a potential health risk for low-volume patients using larger dialysate volumes.

    Product
    Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0704-2020·2019-12-25

    Bio-Signal Group Recalls HydroDot Wave Prep Electroconductive Cream

    Bio-Signal Group Corp. is recalling HydroDot Wave Prep electroconductive cream due to potential contamination with Burkholderia cepacia.

    Product
    HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.…
    Category
    Medical Device
    Distribution
    Distributed nationwide