The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

1076–1100 of 32252

  • SevereFDA (Devices)·Z-1947-2026·2026-05-06

    AIDBAG First Aid Kits with Recalled Blood Glucose Meters Recalled

    North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.

    Product
    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1984-2026·2026-05-06

    Immy Myco DDR Trident Neutralization Buffer B Recalled for Potential Contamination

    Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.

    Product
    Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0686-2026·2026-05-06

    Enoki mushrooms recalled after testing positive for Listeria monocytogenes

    Enoki mushrooms distributed by Hemu Trading are being recalled after the product tested positive for Listeria monocytogenes. 1,056 cases are affected.

    Product
    Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic package; Product of Korea, Keep Refrigerated. Distributed by Hemu Trading Inc. UPC: 8801234567893
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2021-2026·2026-05-06

    Medline and Centurion Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline Industries is recalling Medline and Centurion medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may cause the products to be out-of-specification.

    Product
    Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1827-2026·2026-05-06

    WHILL Model F Powered Wheelchair Bluetooth Communication Vulnerability

    WHILL, INC. is recalling WHILL Model F powered wheelchairs with software versions before HMI 2.23 and MC 1.05 due to a Bluetooth Low Energy (BLE) communication vulnerability identified through the CISA Vulnerability Disclosure Program.

    Product
    WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0499-2026·2026-05-06

    Optase Dry Eye Drops Recalled for Lack of Sterility Assurance

    Scope Health is recalling Optase Dry Eye Intense Drops (Glycerin 0.2%) due to lack of assurance of sterility. The product is distributed nationwide.

    Product
    OPTASE — OPTASE (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1996-2026·2026-05-06

    iLet Bionic Pancreas Software Versions Recalled for Delayed CGM Readings

    Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.

    Product
    iLet Bionic Pancreas, REF: BB1001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1826-2026·2026-05-06

    WHILL Model C2 Powered Wheelchair Recalled for Bluetooth Security Vulnerability

    WHILL Model C2 powered wheelchairs with software versions before HMI 2.22 and MC 1.13 are recalled due to a Bluetooth Low Energy (BLE) communication vulnerability identified by CISA. Approximately 4,685 units distributed in Kansas are affected.

    Product
    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·26V285000·2026-05-05

    Winnebago Recalls 2026-2027 Solis RVs Due to LP Hose Routing Defect

    Winnebago is recalling 2026-2027 Solis recreational vehicles because the liquid propane hose may be routed over the exhaust heat shield, posing a fire risk.

    Product
    WINNEBAGO — WINNEBAGO SOLIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V275000·2026-04-30

    Nova Bus LFS transit buses may lose drive power from data overload

    Nova Bus is recalling certain 2022-2023 LFS transit buses because a telemetry control unit may cause a data overload, shutting down the unit and causing a loss of drive power.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26456·2026-04-30

    Boo Bunnie toy cubes can break into small parts and sharp edges

    Stephan Baby Boo Bunnie and Friends toys are recalled after 20 reports of the water-filled cube cracking or breaking, including one case where a child swallowed sharp pieces.

    Product
    Stephan Baby Boo Bunnie and Friends Children's Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V276000·2026-04-30

    Grand Design Lineage solar panels may detach from the roof

    Grand Design is recalling certain 2025-2026 Lineage recreational vehicles because the adhesive securing the roof solar panels may fail, allowing a panel to detach into the roadway.

    Product
    GRAND DESIGN — GRAND DESIGN LINEAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V277000·2026-04-30

    Grand Design Lineage driver and passenger seat bases may be loose

    Grand Design is recalling certain 2025-2026 Lineage recreational vehicles because the driver and passenger seat bases may not have been tightened properly, breaching FMVSS 207.

    Product
    GRAND DESIGN — GRAND DESIGN LINEAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26458·2026-04-30

    Honda CRF off-road motorcycle handlebars can rotate at the clamp

    Honda is recalling model year 2025-2026 CRF250R and CRF450R off-road motorcycles because the handlebar clamp can allow the handlebar to rotate unexpectedly. One crash reported.

    Product
    Model Year 2025-2026 CRF250R/RX/RWE and CRF450R/RX/RWE Off-Road Motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26444·2026-04-30

    Thermos food jar stoppers can eject forcefully and cause eye injuries

    Thermos Stainless King food jars and Sportsman bottles are recalled after 27 reports of stoppers ejecting forcefully on opening, including three consumers with permanent vision loss.

    Product
    Thermos Stainless King 3000 and 3020 Food Jars and Thermos Sportsman 3010 Food & Beverage Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·26E024000·2026-04-29

    Dorman Recalls Transmission Gearshift Cables Due to Bushing Detachment Risk

    Dorman is recalling specific transmission gearshift cables where the bushing may detach, preventing the vehicle from shifting into Park and increasing the risk of a crash.

    Product
    POWER TRAIN:SHIFT LINKAGE/CABLE/ROD recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1876-2026·2026-04-29

    Medline 10mL Polycarbonate Syringes in Convenience Kits recalled

    Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The kits were distributed nationwide in the US and to Canada, Panama, and Barbados.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1886-2026·2026-04-29

    Medline Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes (Eye Pack and Heart Cath Pack) due to unapproved design changes made outside of FDA 510(k) clearance.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1869-2026·2026-04-29

    Soft-Vu Angiographic Catheter Recalled Due to Manufacturing Defect

    Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter (Straight Art, Non-Braided) units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.

    Product
    Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0496-2026·2026-04-29

    Dextrose Injection USP recalled due to sterility assurance concerns

    B. Braun Medical Inc. is recalling Dextrose Injection USP 70% in 2000 mL bags nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1879-2026·2026-04-29

    Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes

    Medline Industries, LP is recalling Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed worldwide.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2026·2026-04-29

    Medline angiography and catheter kits subject to rescinded regulatory clearances

    Medline Industries is recalling 12 types of angiography and catheter kits because their 510(k) regulatory clearances have been rescinded. The kits were distributed nationwide.

    Product
    Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1867-2026·2026-04-29

    Soft-Vu Angiographic Catheter Soft-Vu SO1 recalled for manufacturing defect

    Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1845-2026·2026-04-29

    Medline Labor Pack medical device kits regulatory clearance rescinded

    Medline Industries is recalling certain Labor Pack kits (Model DYNJ44813D) nationwide because their 510(k) regulatory clearances for Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.

    Product
    Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1843-2026·2026-04-29

    Control Syringes and Related Devices FDA Regulatory Clearances Rescinded

    Medline Industries has recalled Control Syringes (Model DNSC89369 and DYNJSYR10C), Guidewires, and High-Pressure Tubing after their FDA 510(k) regulatory clearances were rescinded. The devices were distributed nationwide.

    Product
    Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
    Category
    Medical Device
    Distribution
    Distributed nationwide