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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16476–16500 of 39988

  • HighFDA (Devices)·Z-2741-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall

    CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because loose or missing screws may cause power loss and therapy interruption.

    Product
    Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    55 states
  • HighFDA (Devices)·Z-2754-2020·2020-08-12

    BD MAX SARS-CoV-2 Reagents Recalled for Potential False Positive Results

    Becton Dickinson is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results, which could delay diagnosis and increase exposure risk.

    Product
    BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2762-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing prolonged procedures or tissue damage.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2765-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2760-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2717-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall

    CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 infusion pumps because cleaning agents may damage connectors, potentially interrupting therapy or monitoring.

    Product
    Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2756-2020·2020-08-12

    Siemens Luminos Agile Max Recalled for Software Collision and Image Errors

    Siemens Medical Solutions is recalling 477 Luminos Agile Max units due to software defects that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2020·2020-08-12

    Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Delivery

    Smiths Medical is recalling Medfusion Syringe Pump Model 3500 units because inaccurate delivery can occur after an interrupted Bolus or Loading dose.

    Product
    Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2757-2020·2020-08-12

    Siemens Uroskop Omnia Max Recalled for Software Collision and Image Errors

    Siemens is recalling 194 Uroskop Omnia Max units due to software issues that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2764-2020·2020-08-12

    Boston Scientific Recalls Captiflex Snares Due to Potential Cutting Failure

    Boston Scientific is recalling specific lots of Captiflex Snares because they may fail to cut polyps, potentially causing tissue damage or bleeding.

    Product
    Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2721-2020·2020-08-12

    CareFusion Alaris EtCO2 Module Recall Due to Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.

    Product
    Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2753-2020·2020-08-12

    Randox Lipase Assay Substrate Recalled for Imprecision in Quality Control

    Randox Laboratories is recalling specific batches of Lipase R2 Substrate due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2749-2020·2020-08-12

    Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Compromise

    Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.

    Product
    Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2747-2020·2020-08-12

    Siemens DCA Vantage Barcode Scanner Recalled for Data Integrity Issues

    Siemens Healthcare is recalling 1,800 DCA Vantage Handheld Barcode Scanners because they may fail to verify check digits or incorrectly process barcodes, potentially leading to data errors.

    Product
    DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2752-2020·2020-08-12

    Randox Lipase Assay Buffer Recalled for Imprecision in Quality Control

    Randox Laboratories is recalling specific batches of Lipase Colorimetric R1 Buffer due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2751-2020·2020-08-12

    Randox Lipase Assay Reagent Recalled for Imprecision in Quality Control and Patient Samples

    Randox Laboratories is recalling specific batches of Lipase Colorimetric Reagent due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2746-2020·2020-08-12

    Smith & Nephew Recalls SUTUREFIX ULTRA Suture Due to Packaging Error

    Smith & Nephew is recalling 868 units of SUTUREFIX ULTRA Suture because a packaging error caused an XL drill to be included instead of the correct S drill.

    Product
    SUTUREFIX ULTRA Suture, Product number 72203855
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2744-2020·2020-08-12

    Sutter Swyng Non-Stick Bipolar Forceps Recalled for Incorrect Package Insert Labeling

    Sutter Medizintechnik GmbH is recalling 1,337 units of Sutter Swyng non-stick bipolar forceps because the package insert incorrectly displays the Ethylene Oxide sterilization symbol instead of the irradiation symbol.

    Product
    Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2729-2020·2020-08-05

    Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 20,600 units distributed nationwide.

    Product
    Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2738-2020·2020-08-05

    Hill-Rom Recalls 1,033 Centralia Smart+ Beds Due to Screw Defect

    Hill-Rom is recalling 1,033 Centralia Smart+ Beds because screws may not meet tensile strength requirements, posing a risk of serious injury.

    Product
    Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2737-2020·2020-08-05

    Hill-Rom Recalls Progressa Beds Due to Screw Tensile Strength Defect

    Hill-Rom is recalling 257 Progressa Beds because screws may not meet tensile strength requirements, posing a risk of serious injury to patients or users.

    Product
    Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2742-2020·2020-08-05

    OrthoPediatrics Recalls Spine Rods Due to Potential Fracture Risk

    OrthoPediatrics Corp is recalling 73 units of 6.0MM spine rods because incorrect laser etching may compromise strength and lead to unintended fracture.

    Product
    Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2725-2020·2020-08-05

    Medline Recalls ClearPro Trach T-Piece Closed Suction Catheters

    Medline is recalling 680 units of ClearPro Trach T-Piece Closed Suction Catheters because the catheter may come apart from the device assembly during use.

    Product
    ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2708-2020·2020-08-05

    TTDEYE Black Starshine Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Black Starshine colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2020·2020-08-05

    Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage

    Teleflex Medical Inc. is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall affects 75,320 units distributed nationwide.

    Product
    Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide