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.

426–450 of 4878

  • SevereFDA (Food)·F-0371-2025·2025-01-08

    Kowalski's Garden Salad Recalled for Potential Salmonella Contamination

    Kowalski's Garden Salad (14 oz) is recalled due to potential Salmonella contamination in cucumbers. The recall affects 206 units distributed across 11 states with use/sell by dates November 6-15, 2024.

    Product
    Kowalski's Garden Salad Net Wt. 14oz. Keep Refrigerated. UPC 7 95631-89335 9. Containing Lettuce, Cucumber, Tomatoes, Broccoli, Cheddar Cheese, Onion, Hard Cooked Eggs, Carrots, Roasted Sunflower Kernels.
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·23V373000·2025-01-05

    2021-2023 Autocar Xpeditor trucks recalled for defective door latch

    Autocar is recalling 2021-2023 Xpeditor commercial trucks due to incorrectly assembled right-side door latches that may open unexpectedly during operation. Owners should contact Autocar for a free inspection and reassembly.

    Product
    AUTOCAR — 2021 AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0708-2025·2025-01-01

    Cardiac Monitoring Software Failed to Properly Route ECG Events

    Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.

    Product
    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0683-2025·2025-01-01

    Blood glucose ketone meter software bug causes erroneous result transmission

    Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.

    Product
    StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V026000·2025-01-01

    2022-2023 BMW i4 and iX Vehicles Lack Pedestrian Warning Sounds

    BMW is recalling 2022-2023 i4 eDrive40 and iX xDrive50 electric vehicles because the external pedestrian warning sound system may fail during start-up. Pedestrians could be unaware of approaching vehicles, increasing injury risk.

    Product
    BMW — 2023 BMW I4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0313-2025·2025-01-01

    Raw Cucumbers Recalled for Potential Salmonella Contamination Risk

    SunFed Produce, Inc. is recalling raw cucumbers distributed nationally and internationally due to potential Salmonella contamination. The recall affects 71,070 cases.

    Product
    Raw cucumbers packaged in cardboard boxes or plastic boxes (RPC) with "SunFed", "Vegetables", or "Agrotato" labeling. 1 1/9 BU CAS Super Slicer Cucumber/10814780010749 1 1/9 BU CAS Select Slicer Cucumber/10814780010756 1 1/9 BU CAS Large Slicer Cucumber/10814780010763 1 1/9 BU
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0682-2025·2025-01-01

    Blood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results

    Software bug in StatStrip Glucose Ketone Hospital Meter System can cause incorrect blood glucose and ketone test results to be transmitted to healthcare data systems. 347 units affected.

    Product
    StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0681-2025·2025-01-01

    Glucose Hospital Meter Software Bug Transmits Inaccurate Results

    StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.

    Product
    StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·25080·2024-12-26

    Inclusive Orbit merry-go-rounds recalled due to finger crush hazard

    About 415 Inclusive Orbit merry-go-rounds are recalled due to a crushing hazard where the gap between the rotating platform and outer rim narrows, trapping children's fingers. Two finger crushing injuries have been reported.

    Product
    Inclusive Orbit merry-go-rounds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25078·2024-12-26

    Precor Resolute cable exercise equipment recalled for pulley drop hazard

    Precor recalls about 834 Resolute Cable exercise units; the pop-pin can fail, causing the pulley carriage to drop unexpectedly. The company received 9 reports of pulley drops, including 2 minor head injuries.

    Product
    Precor Resolute Cable Multi-Station Exercise Equipment
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0290-2025·2024-12-25

    Carrot falafel product recalled for potential E. coli contamination

    Fabalish Inc.'s Kickin brand carrot falafel is being recalled due to potential E. coli contamination. Consumers should not consume the product.

    Product
    Fabalish Inc. , Kickin, Carrot Falafel , 10oz , Cardboard tray inside plastic film inside cardboard box, individual units
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-0668-2025·2024-12-25

    FDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure

    Draeger Medical recalls the Atlan A300XL anesthesia workstation for potential piston ventilator failure that could occur before use or during anesthesia delivery. Twenty-five units were distributed outside the United States.

    Product
    Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0303-2025·2024-12-25

    Fresh cucumber dices recalled for possible Salmonella contamination

    Field Fresh Foods has recalled Fresh Creative Foods raw cucumber dices due to possible Salmonella contamination associated with an outbreak. The product was distributed in California.

    Product
    Fresh Creative Foods, raw cucumber diced (1/4 cubes.) with skin, Net Wt. 20lbs. (4x5lbs.)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0659-2025·2024-12-25

    Nidek Disposable Bipolar Pencil Surgical Instruments Recalled for Tube Breakage Risk

    Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.

    Product
    Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteriza
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0658-2025·2024-12-25

    Walcott Bipolar Pencil Surgical Instrument Recalled for Potential Tube Detachment

    Kirwan Surgical Products is recalling Walcott Bipolar Pencil 25 Gauge surgical instruments due to potential breakage or detachment of the stainless-steel tube. The affected pencils are used in eye and soft tissue surgery.

    Product
    Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0660-2025·2024-12-25

    Optikon Bipolar Pencil surgical tool recalled for tube failure risk

    FDA recalls Kirwan Surgical's Optikon Bipolar Pencil surgical instruments due to risk that the outer stainless-steel tube may break or detach during use. The recalled devices were distributed worldwide.

    Product
    Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0667-2025·2024-12-25

    Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall

    Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.

    Product
    Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0661-2025·2024-12-25

    Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks

    Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.

    Product
    Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0291-2025·2024-12-25

    Whole Foods Organic Carrot Sticks Recalled for Potential E. coli Contamination

    Whole Foods Market Organic Carrot Sticks potentially contaminated with E. coli O121:H19 are being recalled. The recall affects 407 cases distributed in AZ, CA, HI, ID, and NV.

    Product
    WHOLE FOODS MARKET, Organic Carrot Sticks, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eat
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0654-2025·2024-12-25

    Kirwan Surgical Disposable Bipolar Pencils recalled for potential tube failure

    Kirwan Surgical Products is recalling 80,060 Disposable Bipolar Pencils (Model 14-5011) because the outer stainless-steel tube may break or detach during surgical use. The devices were distributed worldwide.

    Product
    Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0302-2025·2024-12-25

    Baker Farms Curly Mustard Recalled for Listeria Contamination

    Baker Farms Curly Mustard 16 oz bags are being recalled due to contamination with Listeria monocytogenes. The product was distributed to distribution centers in nine states.

    Product
    Baker Farms CURLY MUSTARD 16 oz NET WT 16 oz UPC 8 13098 02018 4 Baker Farms 3667 Ellenton-Norman Park Road Norman Park, GA 31771
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0662-2025·2024-12-25

    Exacta External Drainage System Stopcocks May Leak or Crack

    Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.

    Product
    Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0655-2025·2024-12-25

    Kirwan Surgical Bipolar Pencil Recalled Due to Potential Tube Breakage

    Kirwan Surgical Products is recalling its Disposable 25-gauge Bipolar Pencil (Model 14-5011L) because the outer stainless-steel tube may break or detach during use. The defect could create a safety hazard during eye surgery and other soft tissue procedures.

    Product
    Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0656-2025·2024-12-25

    Surgical Bipolar Pencil Recall: Risk of Tube Breakage During Eye Surgery

    Kirwan Surgical Products is recalling disposable bipolar surgical pencils used in eye surgery because the outer stainless-steel tube may break or detach during use.

    Product
    Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·25071·2024-12-19

    SKIL 40V 5.0Ah Lithium-Ion Batteries Recalled for Fire and Burn Hazard

    SKIL 40V batteries sold from 2019–2024 can overheat, causing fires and burns. Chervon reports 100 thermal incidents, including 8 burn/smoke cases and 49 property damage claims.

    Product
    SKIL 40V 5.0 Ah Lithium-Ion Batteries
    Category
    Consumer Product
    Distribution
    Distributed nationwide