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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11001–11025 of 40095

  • HighFDA (Devices)·Z-0741-2023·2022-12-28

    InPen Diabetes App crashes, preventing dose reminders

    The InPen Diabetes Management App may crash on certain Android versions, preventing dose reminders and potentially delaying insulin therapy. This could affect users of the diabetes management system.

    Product
    InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2023·2022-12-28

    DeVilbiss 525 Oxygen Concentrator Recalled Due to Excessive Heat

    DeVilbiss is recalling the 525 oxygen concentrator because the device can become excessively hot, with external parts potentially exceeding 105.8 degrees Fahrenheit. The firm has updated the user manual to include additional safety warnings.

    Product
    DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2023·2022-12-28

    GE B105M Patient Monitor displays inaccurate CO2 readings at altitude

    GE Medical Systems is recalling B105M patient monitors that display inaccurate CO2 readings when used at elevations above sea level. The issue affects monitors showing CO2 in mmHg or kPa units.

    Product
    B105M Patient Monitor, REF 6160000-003
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0754-2023·2022-12-28

    Vivid S5 N Ultrasound Systems Recalled for Potential Battery Fire Hazard

    GE Medical Systems recalled 1,400 Vivid S5 N ultrasound systems for batteries that may fail, emit smoke, or catch fire if not replaced every 2 years as recommended.

    Product
    Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2023·2022-12-28

    Corin BIOLOX DELTA ceramic hip replacement heads mislabeled with incorrect sizes

    Corin Ltd is recalling BIOLOX DELTA ceramic hip replacement heads because some units are labeled with incorrect sizes. The recall affects 12 units distributed in seven U.S. states.

    Product
    Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2023·2022-12-28

    Tobra Bone Cement Recall for Missing Turkish Instructions

    Howmedica Osteonics is recalling Tobra bone cement because packaging instructions lack Turkish language translation, though the instructions themselves are accurate. The recall affects 20 units distributed internationally.

    Product
    Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0736-2023·2022-12-28

    Bone Cement Recall: Missing Turkish Language Instructions for Use

    Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the included instructions for use lack Turkish language translations. The product content itself is accurate; only the language translation is missing.

    Product
    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0725-2023·2022-12-28

    Intradental periodontal picks recalled for mislabeling by Young Dental

    Young Dental Manufacturing has recalled Denticator PICK-A-DENT intradental picks due to mislabeling. The recall affects 600 packs distributed in Iowa, New York, Pennsylvania, Tennessee, Texas, and Canada.

    Product
    Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0729-2023·2022-12-28

    GE Patient Monitors May Display Inaccurate CO2 Readings at Non-Sea-Level Locations

    GE Healthcare is recalling certain B105P patient monitors because they may display inaccurate CO2 measurements when used in locations not at or near sea level with mmHg or kPa units selected.

    Product
    B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·23081·2022-12-22

    Nova Medical Home Bed Rails Recalled Due to Entrapment and Asphyxia Risk

    Nova Medical Products is recalling approximately 20,000 Home Bed Rails (Models 6093 and 6094) because users can become entrapped within the bed rail or between the rail and mattress, posing a serious risk of death by asphyxiation.

    Product
    Home Bed Rails
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0438-2023·2022-12-21

    Arrow AC3 Optimus IABP recalled for shortened battery run-times

    Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) devices are recalled worldwide due to a potential issue with shortened battery run-times. All lot and serial numbers of model IAP-0700 are affected.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0436-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Runtime Issue

    Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times. All lot and serial numbers worldwide are affected.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0434-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Run-Time Issue

    ARROW INTERNATIONAL is recalling Arrow AutoCAT2 Intra-Aortic Balloon Pumps due to a potential issue with short battery run-times. Affected devices distributed worldwide may have reduced battery endurance.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0428-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

    Arrow AutoCAT2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The recall affects 12 units distributed worldwide.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0439-2023·2022-12-21

    Arrow AC3 Optimus cardiac pump recalled due to battery issues

    Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide are being recalled due to short battery run-times. All lot and serial numbers are affected.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0431-2023·2022-12-21

    Arrow AutoCAT2 Cardiac Pump Recalled for Short Battery Run-Time Risk

    Arrow International is recalling the AutoCAT2 intra-aortic balloon pump (model AEROAUTOCAT 2 WAVE) due to a potential issue with short battery run-times that may affect patient cardiac support.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0450-2023·2022-12-21

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Short Battery Run-Time

    Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The Class I recall affects 48 units distributed worldwide.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0448-2023·2022-12-21

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump recalled for short battery runtime

    Arrow AutoCAT2WAVE IABP devices have been recalled due to a potential issue with short battery run-times. The recall covers 112 units distributed worldwide.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0440-2023·2022-12-21

    Arrow AC3 Optimus intra-aortic balloon pump short battery runtime

    Arrow AC3 Optimus cardiac pumps may experience short battery run-times. The FDA has issued a Class I recall for all units worldwide.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0435-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

    Arrow AutoCAT2 intra-aortic balloon pumps may experience shorter battery run-times than specified, affecting device reliability in cardiac care. The FDA has issued a Class I recall for all affected units worldwide.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0429-2023·2022-12-21

    Arrow AutoCAT2 cardiac pump recalled for short battery run-times

    Arrow International is recalling 2,678 Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with short battery run-times. The FDA classified this as a Class I recall.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0447-2023·2022-12-21

    Arrow AutoCAT2WAVE intra-aortic balloon pump recalled for short battery run-times

    Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled for a potential issue with short battery run-times. The FDA Class I recall affects 39 units distributed worldwide, manufactured by Arrow International Inc.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0443-2023·2022-12-21

    Arrow AC3 Optimus Intra-Aortic Balloon Pump Battery Failure Recall

    Arrow International recalls AC3 Optimus intra-aortic balloon pumps worldwide due to short battery run-times. The FDA issued a Class I recall affecting all lot and serial numbers.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0352-2023·2022-12-21

    Central Venous Catheter Kits Recalled for Potential Connector Housing Failure

    ARROW INTERNATIONAL is recalling 1,275 units of Arrowg+ard Blue Plus CVC kits due to inadequate connections in Micro Clave Clear Connectors. Units distributed in six states.

    Product
    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer
    Category
    Medical Device
    Distribution
    6 states