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.

15526–15550 of 53092

  • HighFDA (Devices)·Z-0128-2023·2022-11-02

    ConvaTec Esteem+ Durahesive Plus Ostomy Pouch Release Liner Defect

    ConvaTec recalled 182 units of Esteem+ Durahesive Plus ostomy pouches nationwide due to impaired release liner functionality. The defect affects pouches with batch number 2A02671 and UDI 768455115334.

    Product
    ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22E093000·2022-11-02

    ITR Recalls Oasis Chinook Hydronic Heaters Due to Fuel Line Defect

    International Thermal Research is recalling Oasis Chinook Hydronic Heaters because an air line may be installed instead of a fuel line, creating a fire risk.

    Product
    FUEL SYSTEM, DIESEL:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V858000·2022-11-02

    2021 Volkswagen ID.4 Passenger Air Bag May Fail to Deploy Properly

    Volkswagen is recalling certain 2021 ID.4 vehicles because the passenger air bag may be incorrectly folded and could fail to protect occupants during a crash.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2023·2022-11-02

    ConvaTec Ostomy Pouch Recalled for Impaired Release Liner Functionality

    ConvaTec is recalling 2,611 units of its Active Life ostomy pouch due to impaired release liner functionality. The defect may affect product performance and seal integrity.

    Product
    ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2023·2022-11-02

    ConvaTec Esteem+ Durahesive Plus ostomy pouches recalled for release liner defect

    ConvaTec is recalling 5,284 units of Esteem+ Durahesive Plus ostomy pouches due to impaired release liner functionality. The defect may affect proper device operation for patients managing colostomy or ileostomy output.

    Product
    ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0073-2023·2022-11-02

    Indian Gooseberry Extract Recalled for Elevated Lead Levels

    Secrets of the Tribe is recalling Indian Gooseberry Alcohol-Free Extract (2 oz and 4 oz bottles) distributed nationwide due to elevated lead levels. Consumers should stop using the product.

    Product
    Indian Gooseberry Alcohol-Free Extract, 2 oz. glass bottle, UPC 722267094379 and Indian Gooseberry Alcohol-Free Extract, 4 oz. glass bottle, UPC 722267094393, Secrets of the Tribe LLC, PO Box 5264, Denver, CO, 80217
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·22V820000·2022-11-02

    2023 BMW X5 and X7 Windshield Bonding Defect Poses Fire Risk

    BMW is recalling 2023 X5 and X7 models with windshield bonding defects that may allow water to enter the vehicle and cause an electrical short-circuit, increasing fire risk.

    Product
    BMW — BMW X7, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0016-2023·2022-11-02

    Proton Armor hand sanitizer recalled for methanol contamination

    Ultra Chem Labs Corp is recalling Proton Armor hand sanitizer nationwide due to trace amounts of methanol found in a manufacturing component. No illnesses have been reported.

    Product
    Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2023·2022-11-02

    AutoPulse Resuscitation System Battery Recalled for Increased Li-ion Failures

    ZOLL Circulation is recalling 6,353 AutoPulse Li-ion Batteries used in the AutoPulse Resuscitation System Model 100 CPR device due to an increase in battery failures. Affected users should contact the manufacturer for replacement guidance.

    Product
    AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0134-2023·2022-11-02

    ARIES SARS-CoV-2 Assay Recalled Due to Syringe Defect

    Luminex is recalling certain lots of the ARIES SARS-CoV-2 Assay because a defect in the wash 1 syringe could cause incomplete sample extraction and produce false negative test results.

    Product
    ARIES SARS-CoV-2 Assay, REF: 50-10047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0017-2023·2022-11-02

    Proton Armor Hand Sanitizer Recalled Due to Methanol Contamination

    Ultra Chem Labs Corp is recalling Proton Armor Anti-Microbial Alcohol-Free Foaming Hand Sanitizer nationwide due to trace amounts of methanol found in product components during manufacturing. The recall affects multiple bottle sizes with batch number 20117206.

    Product
    Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0020-2023·2022-11-02

    Fondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation

    AuroMedics Pharma LLC is recalling 11,520 units of Fondaparinux Sodium Injection nationwide due to out-of-specification potency. Patients should contact their healthcare provider immediately.

    Product
    FONDAPARINUX SODIUM — FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0072-2023·2022-11-02

    Secrets of the Tribe Amla Alcohol-Free Extract recalled for elevated lead

    Secrets of the Tribe is recalling Amla Alcohol-Free Extract (2 oz and 4 oz bottles) distributed nationwide due to elevated lead levels.

    Product
    Amla Alcohol-Free Extract, 2 oz. glass bottle, UPC 041979376093 and Amla Alcohol-Free Extract, 4 oz. glass bottle, UPC 041979376116, Secrets of the Tribe LLC, PO Box 5264, Denver, CO, 80217
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2023·2022-11-02

    Stryker INBONE Tibial Tray Recalled Due to Oversized Lock Detail

    Stryker INBONE Tibial Trays are being recalled due to an oversized lock detail that could affect proper component assembly and implant function. Affected units were distributed in New York.

    Product
    Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0137-2023·2022-11-02

    CorVocet Biopsy System recalled for needle ejection risk from component misalignment

    Merit Medical Systems is recalling CorVocet Biopsy Systems due to manufacturing defects that may cause the needle to eject when triggered outside the body, risking needle stick injuries to users or patients.

    Product
    CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A…
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0125-2023·2022-11-02

    Hip Liner Implants Mixed with Knee Inserts in Packaging

    Encore Medical is recalling EMPOWR hip liner implants because boxes may contain knee inserts instead. This packaging error could delay surgeries. Four units affected in six US states.

    Product
    EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0077-2023·2022-11-02

    Qassim Mix for Coffee Recalled Due to Undeclared Milk Allergen

    Tomoorona LLC is recalling Qassim Mix for Coffee due to undeclared milk in the label. The product contains sodium caseinate (a milk derivative) but does not warn consumers about milk allergen, risking harm to those with milk allergies.

    Product
    Qassim Mix for Coffee, Net Weight 125g, packaged in a plastic container (UPC 6-281103 300011). Each case contains 48-125g containers.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0131-2023·2022-11-02

    LINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling

    Datascope's LINEAR intra-aortic balloon catheter has an incorrect balloon volume label on internal instructions that may delay critical therapy in unstable patients.

    Product
    LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V818000·2022-11-01

    2017-2021 Tesla Model S and Model X power steering assist loss

    Tesla is recalling 2017-2021 Model S and Model X vehicles due to power steering assist failure on rough roads or after hitting potholes, which increases crash risk.

    Product
    TESLA — TESLA MODEL S, MODEL X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E092000·2022-11-01

    Tesla 2021 Model S Rearview Mirrors Recalled for Visibility Defect

    Tesla is recalling 2021 Model S exterior rearview mirrors that do not meet federal rear-visibility standards. Defective mirrors may cause drivers to misjudge vehicle distances, raising crash risk.

    Product
    TESLA — TESLA MODEL S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V815000·2022-10-31

    Volkswagen and Audi Vehicles Recalled for Tire Pressure Monitoring System Failure

    Volkswagen Group of America is recalling 296,044 Volkswagen and Audi vehicles (model years 2019-2021) because the tire pressure monitoring system may fail to detect simultaneous pressure loss in all four tires, increasing crash risk. Dealers will update the TPMS software at no charge.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI ATLAS CROSS SPORT, Q3, GOLF SPORTWAGEN, A3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V814000·2022-10-31

    Tiffin Motorhomes Recall Multiple 2022-2023 Models for LPG Hose Leak Fire Risk

    Tiffin is recalling approximately 295 motorhomes from 2022-2023 because the LPG hose fitting connected to the regulator may leak at the swivel joint, creating a fire hazard in the presence of an ignition source.

    Product
    TIFFIN — TIFFIN RED 360, ALLEGRO BAY, ALLEGRO BREEZE, PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V812000·2022-10-28

    Micro Bird Recalls One 2019 G5 Transit Bus for Brake Fluid Leak

    Micro Bird is recalling one 2019 G5 transit bus because a faulty connection may cause power steering fluid loss, reducing brake assist and increasing crash risk.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23704·2022-10-27

    Amazon Basics Executive Desk Chairs Recalled for Fall and Injury Hazards

    Amazon is recalling about 11,400 Amazon Basics Executive Desk Chairs because the leg base can break, creating a fall and injury hazard. The company has received 13 reports of breaking leg bases, including one report of a minor shoulder injury.

    Product
    Amazon Basics Executive Desk Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide