The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

5801–5825 of 29108

  • SevereFDA (Devices)·Z-0441-2023·2022-12-21

    Arrow AC3 Optimus Intra-Aortic Balloon Pumps recalled for short battery runtime

    Arrow International is recalling Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. The pumps may not operate for the intended duration during critical cardiac care.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0445-2023·2022-12-21

    Arrow AutoCAT 2 Cardiac Pump Recalled for Potential Battery Runtime Issue

    Arrow International is recalling Arrow AutoCAT 2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), 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 (Drugs)·D-0080-2023·2022-12-21

    FDA Recalls Sodium Bicarbonate Injection Vials for Glass Breakage Risk

    Exela Pharma Sciences is recalling Sodium Bicarbonate Injection vials due to defective containers that may break and release glass fragments when pressurized during preparation. The recall affects 37,320 vials distributed nationwide.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0452-2023·2022-12-21

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Battery Runtime Issues

    Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0442-2023·2022-12-21

    Arrow AC3 Optimus IABP Devices Recalled for Short Battery Run-Time Issue

    Arrow AC3 Optimus Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. The FDA issued a Class I recall for these devices.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), 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
  • SevereFDA (Drugs)·D-0086-2023·2022-12-21

    Injectable iohexol syringes recalled for mislabeled iodine strength

    BayCare Integrated Service Center is recalling 250 iohexol injection syringes mislabeled as 300 mg iodine/mL but actually containing 350 mg iodine/mL. The labeling error could result in dosing mistakes.

    Product
    Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 30
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0446-2023·2022-12-21

    Arrow AutoCAT 2 Cardiac Pump Recalled for Battery Runtime Issues

    Arrow AutoCAT 2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. Affected users should contact the manufacturer for guidance.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0426-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump recalled for short battery run-times

    Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0454-2023·2022-12-21

    Intra-Aortic Balloon Pump Battery Run-Time Issue Recall

    Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0079-2023·2022-12-21

    FDA Recalls Sodium Bicarbonate Injection for Defective Vials

    Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-0444-2023·2022-12-21

    Arrow AutoCAT 2 Intra-Aortic Balloon Pump Short Battery Runtime Recall

    Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0455-2023·2022-12-21

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

    Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·22V943000·2022-12-20

    New Flyer Transit Buses Recalled for Steering Column Defect

    New Flyer is recalling 746 transit buses because a loose steering column connection may cause loss of steering, increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XT40, XDE35, XN40, XT60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V942000·2022-12-19

    2023 BMW X5 driver seat backrest fastener defect recall

    BMW is recalling certain 2023 X5 models because one of four bolts connecting the driver's seat backrest to the frame may not have been correctly installed, potentially preventing proper occupant restraint during a crash.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V936000·2022-12-16

    Mercedes-Benz Recalls GLE and GLS Models for Steering Screw Defect

    Mercedes-Benz is recalling 2021-2022 GLE and GLS vehicles because a steering coupling locking screw may loosen, potentially causing a loss of steering control.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, AMG GLE63, GLS 450 4MATIC, AMG GLE53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V941000·2022-12-16

    Hyundai Recalls 2021 Kona Electric Vehicles Due to EPCU Coolant Leak Risk

    Hyundai is recalling 2021 Kona Electric vehicles because a defective Electric Power Control Unit may leak coolant, potentially causing a loss of drive power and increasing crash risk.

    Product
    HYUNDAI — HYUNDAI KONA ELECTRIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V934000·2022-12-16

    Lightning eMotors Recalls FE4 Vehicles for Battery Power Loss Risk

    Lightning eMotors is recalling 2021-2022 FE4-129 vehicles because the high-voltage battery may lose traction power or fail to start, increasing crash risk.

    Product
    LIGHTNING EMOTORS — LIGHTNING EMOTORS FE4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V939000·2022-12-16

    Peterbilt 320 and 520 Refuse Trucks Recalled for Suspension Defect

    PACCAR is recalling 2015-2023 Peterbilt 320 and 520 refuse trucks because suspension brackets may fail, causing axle instability and increasing crash risk.

    Product
    PETERBILT — PETERBILT 320, 520
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V937000·2022-12-16

    Mercedes-Benz Recalls 2022 AMG G63 Due to Rear Axle Defect

    Mercedes-Benz is recalling 278 2022 AMG G63 vehicles because the rear axle differential housing may crack or break, potentially causing loss of control.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG G63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V930000·2022-12-15

    Chevrolet Bolt EV Pretensioner Exhaust Fire Risk Recall

    General Motors recalls 2017-2023 Chevrolet Bolt EV vehicles. After a crash with pretensioner deployment, pretensioner exhaust may ignite carpet near the B-pillar, creating a fire hazard.

    Product
    CHEVROLET — CHEVROLET BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23716·2022-12-15

    Gyroor C3 E-Bikes Recalled for Fire and Burn Hazards

    Gyroor C3 e-bikes are recalled because the battery pack can ignite, creating fire and burn hazards. Gyroor has received reports of battery packs igniting and injuries requiring medical treatment, including burns and smoke inhalation.

    Product
    Gyroor C3 e-bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide