The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

19501–19525 of 50410

  • HighFDA (Devices)·Z-2298-2021·2021-08-25

    DELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect

    Delta Med is recalling DELTAVEN Y IV Catheters in Florida and Minnesota due to potential sterilization defects. The devices may not be properly sterilized, posing infection risks to patients.

    Product
    DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2021·2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall

    W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.

    Product
    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2297-2021·2021-08-25

    IV Catheters recalled due to potential sterilization failure

    229,320 DELTAVEN FASTFLASH IV catheters distributed in Florida and Minnesota are being recalled due to sterilization defects. The medical devices may not be sterile, posing contamination and infection risks to patients.

    Product
    DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2021·2021-08-25

    Dual Balloon Angioplasty Catheter Recalled for Balloon Deflation Difficulty

    Ostial Corporation is recalling the FLASH Ostial System dual balloon angioplasty catheter due to a manufacturing issue that may prevent proper balloon deflation, potentially causing access site complications.

    Product
    FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2021·2021-08-25

    Hitachi L43K intraoperative probe recall: screw cover may detach during sterilization

    Hitachi Healthcare is recalling 120 Model L43K intraoperative probes because the screw cover at the probe tip may fall off after cleaning and sterilization. Facilities should inspect probes before and after sterilization and before and after each surgical use.

    Product
    Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21C003000·2021-08-24

    Dorel Maxi-Cosi Pria 85 Child Seat Recall for Tether Anchor Defect

    Dorel is recalling Maxi-Cosi Pria 85 convertible child seats because they may not adequately protect children from head injury if installed with only a lap belt.

    Product
    CHILD SEAT:VEHICLE TETHER ANCHOR recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V654000·2021-08-23

    PL Custom Recalls 2021 Ford E-450 Emergency Vehicle for LCD Defect

    PL Custom is recalling one 2021 Ford E-450 emergency vehicle because its LCD display may freeze or fail, potentially delaying emergency efforts.

    Product
    PL CUSTOM — PL CUSTOM TYPE III
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V652000·2021-08-23

    2021 Ford Explorer and Lincoln Aviator side air bag assembly defect

    Ford and Lincoln are recalling certain 2021 Explorer and Aviator vehicles. Side air bag attachment weld studs may detach during deployment, potentially failing to provide proper protection in a crash.

    Product
    FORD — FORD, LINCOLN EXPLORER, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V649000·2021-08-20

    Chevrolet Malibu and Cadillac XT4 seat belt fastener defects

    General Motors is recalling certain 2016-2021 Chevrolet Malibu and 2019-2021 Cadillac XT4 vehicles because rear seat belt retractors may be improperly secured with loose or missing fasteners, potentially affecting safety in a crash.

    Product
    CADILLAC — CADILLAC, CHEVROLET XT4, MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V650000·2021-08-20

    Chevrolet Bolt EV battery fire hazard recall for defective modules

    General Motors is recalling 2020-2022 Chevrolet Bolt EV and 2022 Bolt EUV vehicles. The high-voltage battery could catch fire when charged to full or nearly full capacity, increasing risk of injury.

    Product
    CHEVROLET — CHEVROLET BOLT EUV, BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V651000·2021-08-20

    2022 Volkswagen Taos Fuel Supply Connector Detachment Recall

    Volkswagen is recalling certain 2022 Taos vehicles because the underhood fuel supply quick-connector may detach from the fuel line, creating fuel leaks that increase risks of engine stalling and fire.

    Product
    VOLKSWAGEN — VOLKSWAGEN TAOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21776·2021-08-19

    John Deere Compact Utility Tractors Recalled for Wheel Detachment Risk

    Deere & Company is recalling approximately 200 John Deere compact utility tractors (models 4044M, 4044R, 4052M, 4052R, 4066M, 4066R) because rear wheel spacer bolts can be improperly torqued during manufacturing, causing the wheel to fall off and the tractor to overturn.

    Product
    John Deere compact utility tractors
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21775·2021-08-19

    Infant Bath Seats Recalled Due to Drowning Hazard

    Frieyss infant bath seats fail to meet federal safety standards and can tip over while in use, posing a drowning hazard to babies. About 120 units were sold exclusively online at Amazon.com from March through April 2021.

    Product
    Infant Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2281-2021·2021-08-18

    Edwards PediaSat Oximetry Catheters Recalled for Potential Internal Leaks

    Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.

    Product
    Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-0848-2021·2021-08-18

    5000 Years Foods Sliced Cabbage Kimchi Recalled for Listeria Risk

    5000 Years Foods is recalling sliced cabbage kimchi products sold in multiple container sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially reached customers nationwide through retail distributors.

    Product
    5000 Years Foods SLICED CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz, 64 oz, 32 oz, & 16 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0851-2021·2021-08-18

    5000 Years Foods JULRADO Sliced Cabbage Kimchi Listeria Recall

    5000 Years Foods is recalling JULRADO Sliced Cabbage Kimchi in multiple container sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially nationwide through retail distributors.

    Product
    5000 Years Foods JULRADO SLICED CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz, 64 oz, 32 oz, & 16 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2207-2021·2021-08-18

    Stryker Prime Fifth Wheel Stretcher distributed to residential customers instead of healthcare facilities

    A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.

    Product
    Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2021·2021-08-18

    MYLA Laboratory Software: Potential Test Result Alteration from Software Anomaly

    BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.

    Product
    MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2021·2021-08-18

    Hip implant component recalled due to potential corrosion and failure risk

    Biomet is recalling 11 units of a hip replacement component that could experience inner taper corrosion and failure, potentially requiring surgical intervention. No injuries have been reported.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2021·2021-08-18

    Stretcher Chair Model 5050 Incorrectly Distributed to Residential Customers

    Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.

    Product
    Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2021·2021-08-18

    Stryker Surgistool Model 830 distributed to home users instead of healthcare professionals

    Stryker Medical recalls a surgical support tool that was distributed to home consumers but is intended only for healthcare professionals. The device labeling is correct, but home users may lack training to use it safely.

    Product
    Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0855-2021·2021-08-18

    5000 Years Foods Kimchi Recalled for Listeria Contamination Risk

    5000 Years Foods is recalling NO MSG JULRADO SLICED CABBAGE KIMCHI in multiple sizes due to potential Listeria monocytogenes contamination. The product was distributed from Illinois to retailers potentially nationwide.

    Product
    5000 Years Foods NO MSG JULRADO SLICED CABBAGE KIMCHI in 128 oz, 64 oz, 32 oz, & 16 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide