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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11926–11950 of 27470

  • HighFDA (Devices)·Z-1321-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 19 DiamondTemp Unidirectional Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1322-2021·2021-04-07

    EPIX Therapeutics DiamondTemp Catheter Recalled for Labeling Errors

    EPIX Therapeutics is recalling 13 DiamondTemp Unidirectional Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0318-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 10 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 1,569 ZOMA-Jet 10 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1284-2021·2021-03-31

    Caire Diagnostics Recalls FenomPro Devices Due to Erroneous High FeNO Readings

    Caire Diagnostics is recalling FenomPro devices because calibration drift and software errors may cause erroneously high FeNO readings, potentially leading to premature discontinuation of asthma treatment.

    Product
    CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1280-2021·2021-03-31

    Baxter Recalls Prismaflex Preventative Maintenance Kits Due to Tubing Performance Variability

    Baxter Healthcare is recalling Prismaflex Preventative Maintenance Kits and spare part kits because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1307-2021·2021-03-31

    Biomerieux Recalls VITEK 2 Systems Due to HL7 Software Defect

    Biomerieux is recalling 8,786 VITEK 2 systems worldwide due to a software defect that may cause false susceptible results when using HL7 communication.

    Product
    VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1282-2021·2021-03-31

    Hitachi Arietta 850 Ultrasound System Recalled for Acoustic Output Error

    Hitachi Medical Systems America Inc. is recalling Arietta 850 ultrasound systems with specific software versions due to an error that can cause acoustic output to exceed regulatory limits.

    Product
    Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2021·2021-03-31

    Getinge Operating Table System Recalled for Hydraulic Leakage Risk

    Getinge Group Logistics America, LLC is recalling 4,288 Operating Table Systems due to a potential hydraulic leakage that could cause unintended table movement.

    Product
    Operating Table System
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1308-2021·2021-03-31

    Biomerieux Recalls VITEK 2 Compact Systems Due to HL7 Software Defect

    Biomerieux is recalling VITEK 2 Compact systems because a software defect in HL7 communication may prevent expertised interpretation results from being sent to Laboratory Information Systems.

    Product
    VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1297-2021·2021-03-31

    Stryker S-Series Equipment Management System Recall for Brake Disengagement Risk

    Stryker is recalling S-Series Equipment Management Systems because capacitive touch controls may disengage when electrocautery devices are in use.

    Product
    S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2021·2021-03-31

    Olympus Recalls TJF-Q190V Duodenoscopes Due to Reported Mucosal Injury

    Olympus is recalling 1,564 TJF-Q190V duodenoscopes and accessories worldwide due to complaints of mucosal injury associated with the forceps elevator region.

    Product
    Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2021·2021-03-31

    RayCare 3B Oncology Software Recalled for Data Loss During Upgrade

    RaySearch Laboratories AB is recalling RayCare 3B software because patient messages may be lost when upgrading from RayCare 2.

    Product
    RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2021·2021-03-31

    Teleflex Recalls Rusch Polaris Laryngoscopes Due to Handle Cracking

    Teleflex is voluntarily recalling Rusch Polaris laryngoscopes because customers reported that the handles develop cracks or break at the hinge.

    Product
    RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2021·2021-03-31

    Teleflex Recalls PLEUR-EVAC Thoracic Catheters Due to Sterility Concerns

    Teleflex is recalling 520 PLEUR-EVAC Thoracic Catheters because the company cannot guarantee the devices are sterile.

    Product
    PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling 1,225 Prismaflex Control Units used for Continuous Renal Replacement Therapy because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2021·2021-03-31

    Bard Marquee Biopsy Instruments Recalled for Detaching Switch

    Bard Peripheral Vascular Inc is recalling Marquee Disposable Core Biopsy Instruments because the penetration depth switch may detach during use.

    Product
    BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1299-2021·2021-03-31

    Meridian ImmunoCard Mycoplasma EIA Recalled for Potential False-Negative Results

    Meridian Bioscience is recalling 8 ImmunoCard Mycoplasma EIA kits due to incorrect storage that could cause false-negative or invalid results, potentially delaying appropriate patient treatment.

    Product
    The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2021·2021-03-31

    Mizuho Operating Table Hand Control Units Recalled for Sliding Risk

    Mizuho OSI is recalling 26 operating table hand control units because they may cause the tabletop to slide in the opposite direction, potentially delaying surgical procedures.

    Product
    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1287-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheath

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1285-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1286-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1283-2021·2021-03-31

    In2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use

    In2Bones is recalling 60 units of Shannon Percutaneous Burrs due to manufacturing non-conformity that may cause the burr to break during surgery.

    Product
    In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1195-2021·2021-03-24

    Medtronic Custom Perfusion Pack Recalled for Bacterial Endotoxin Levels

    Medtronic is recalling 4 units of Custom Perfusion Packs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1262-2021·2021-03-24

    Merit Medical Recalls HeartSpan Transseptal Needles Due to Tip Curvature Mismatch

    Merit Medical Systems is recalling 587 HeartSpan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.

    Product
    HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a…
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1196-2021·2021-03-24

    Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 70 units of Affinity Pixie Cardiotomy/Venous Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide