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 deaths or serious injuries are reported, 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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

8326–8350 of 27393

  • HighFDA (Devices)·Z-1221-2023·2023-03-15

    CardioMEMS Hospital Electronics System RF Emissions May Interfere With Implanted Devices

    St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.

    Product
    CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physician
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2023·2023-03-15

    CardioMEMS Heart Monitoring System Emissions May Interfere With Pacemakers

    FDA recalls CardioMEMS HF System patient monitor for radiofrequency signal emissions that can interfere with pacemakers, defibrillators, and other implanted medical devices. The emissions exceed radiofrequency limits.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2023·2023-03-15

    TMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval

    A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.

    Product
    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1225-2023·2023-03-15

    CardioMEMS Heart Failure Sensor May Give Inaccurate Readings at High Elevations

    St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2023·2023-03-15

    Sprint 200 Wheeled Stretcher Siderail Labeling Update to Prevent Falls

    FDA is updating labeling for Sprint 200 wheeled stretchers to ensure the siderail is secured to a locked position, preventing potential patient falls and injuries. 335 units (310 US, 25 international) are affected.

    Product
    Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1235-2023·2023-03-15

    Radiation Therapy System Software Issue May Cause Unexpected Dose

    Sensus Healthcare recalls 23 units of the SRT-100 Vision superficial X-ray radiation therapy system due to a software dose timer malfunction that may result in unexpected radiation delivery to patients.

    Product
    Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1210-2023·2023-03-15

    Simplexa Flu A/B & RSV Diagnostic Kits Recalled for Leaking Components

    DiaSorin is recalling 4,142 Simplexa Flu A/B & RSV Direct Gen II diagnostic kits due to leaking Direct amplification Discs that may cause contamination, cross-contamination, invalid test results, and system error codes.

    Product
    Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2023·2023-03-15

    LATITUDE NXT Remote Patient Monitoring System Alerts Not Displaying

    Boston Scientific's LATITUDE NXT system failed to display cardiac alerts for 1,531 patient records during 2022. Contact Boston Scientific to determine if your patients were affected.

    Product
    LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2023·2023-03-15

    CardioMEMS Patient Electronics System Recalled for Excessive Radiofrequency Emissions

    CardioMEMS heart-failure monitoring devices are recalled due to radiofrequency emissions that can interfere with other medical devices like pacemakers when operating nearby.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2023·2023-03-15

    Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk

    Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.

    Product
    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2023·2023-03-15

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalled for helium regulator failure

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2023·2023-03-15

    Blood Sample Collection Kits Shipped With Incorrect Identification Labels

    LetsGetChecked Blood Sample Collection kits were distributed with incorrect shipping labels that assigned samples to wrong users. This could result in incorrect Hepatitis C Virus test results or rejected samples due to demographic mismatches.

    Product
    LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2023·2023-03-15

    COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results

    DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.

    Product
    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1141-2023·2023-03-08

    Life2000 Hospital Ventilator Recalled for Patient Desaturation Risk

    Baxter Healthcare is recalling 8 Life2000 Hospital Ventilator systems due to potential patient desaturation events when the device is connected to an oxygen concentrator.

    Product
    Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1139-2023·2023-03-08

    Life2000 Ventilator System Recall: Risk of Patient Desaturation

    Baxter Healthcare is recalling 4,279 Life2000 Ventilator Systems due to potential patient desaturation when connected to oxygen concentrators.

    Product
    Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1142-2023·2023-03-08

    Life2000 Ventilator poses oxygen desaturation risk with oxygen concentrators

    The FDA recalls Baxter's Life2000 Ventilator due to potential patient desaturation when connected to an oxygen concentrator. Affects 71 units nationwide.

    Product
    Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1140-2023·2023-03-08

    Life2000 Hospital Ventilator Recalled for Potential Patient Desaturation Risk

    Baxter Healthcare is recalling 135 Life2000 ventilators nationwide due to potential patient desaturation when connected to an oxygen concentrator.

    Product
    Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2023·2023-03-08

    Surgipro II Surgical Sutures recalled for sterile barrier breach

    Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.

    Product
    Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2023·2023-03-08

    CustomEyes kits recalled due to potential sterility compromise

    Beaver Visitec International is recalling 4640 units of CustomEyes kits because packaging may contain open seals that could compromise product sterility. Affected units were distributed to 26 U.S. states and internationally.

    Product
    CustomEyes kits
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1188-2023·2023-03-08

    Maquet CARDIOHELP System extracorporeal support device components recalled for sterility

    Maquet is recalling CARDIOHELP System components due to insufficient evidence of packaging sterility. Non-sterile medical devices could expose patients to infection, sepsis, or ischemia.

    Product
    BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2023·2023-03-08

    Med-Riser MR600 Patient Lift Boom Pivot Failure Risk Recall

    Med-Mizer, Inc. is recalling the Med-Riser MR600 Patient Lift due to risk that the boom pivot may fail if the securing nut loosens and the bolt becomes unsecured. Contact the manufacturer for instructions.

    Product
    Med-Riser MR600 Patient Lift
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1196-2023·2023-03-08

    Vascular diagnostic device recalled for air line misconnection risk

    Unetixs Vascular is recalling the MultiLab Series II REVO vascular diagnostic device because faulty connectors may allow the air line to be misconnected to an IV line, potentially causing a dangerous air embolism.

    Product
    MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2023·2023-03-08

    Vascular diagnostic devices recalled due to air embolism misconnection risk

    Unetixs Vascular recalls MultiLab Series II vascular diagnostic devices worldwide due to a design flaw where air lines can be misconnected to IV lines, potentially causing air embolism.

    Product
    MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2023·2023-03-08

    Vascular Diagnostic Device Recalled for Risk of Air Line Misconnection

    Unetixs Vascular recalls MultiLab Series II ROODRA vascular diagnostic devices due to luer fittings that may allow air line misconnection to intravenous lines, potentially causing air embolism.

    Product
    MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2023·2023-03-08

    Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules

    Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.

    Product
    MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide