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.

37501–37525 of 50506

  • HighFDA (Devices)·Z-0096-2016·2015-10-14

    FDA Recalls 924 Sterile Lap Chole Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 924 sterile surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0035-2016·2015-10-14

    Resource Optimization & Innovation Recalls 288 Sterile Vascular Surgical Kits

    Resource Optimization & Innovation LLC is recalling 288 sterile vascular surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0066-2016·2015-10-14

    FDA Recalls 448 Sterile Laparoscopic Cholecystectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 448 sterile surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0088-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Orthopedic Surgical Kits

    Resource Optimization & Innovation LLC is recalling 1,476 sterile orthopedic surgical kits because the equipment glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0034-2016·2015-10-14

    FDA Recalls Sterile Neuro Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 904 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0083-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Total Hip Surgical Kits

    Resource Optimization & Innovation LLC is recalling 24 sterile total hip surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighNHTSA·15V650000·2015-10-13

    Forest River Cherokee Recalled for Incorrect Federal Placard Information

    Forest River is recalling 2013-2014 Cherokee trailers because the Federal placard displays incorrect tire and weight information, which could lead to vehicle overload.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V645000·2015-10-13

    Forest River Recalls 2015-2016 Trailers for Incorrect Tire Placard

    Forest River is recalling specific 2015 Wildwood and 2016 Salem recreational trailers because the tire and wheel placard lists incorrect sizes, which could lead to vehicle instability if the wrong tires are installed.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V636000·2015-10-09

    GM Recalls 2014 Chevrolet Caprice and SS for Airbag Deployment Risk

    General Motors is recalling 2014 Chevrolet Caprice and SS vehicles because a missing seat bracket may cause airbags to deploy with excessive force.

    Product
    CHEVROLET — CHEVROLET CAPRICE, CHEVEROLET SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V637000·2015-10-09

    Ducati Recalls Multistrada Motorcycles Due to Side-Stand Defect

    Ducati is recalling 2015-2016 Multistrada 1200 and 1200 S motorcycles because the side-stand may break, causing the bike to fall over and increasing injury risk.

    Product
    DUCATI — DUCATI MULTISTRADA 1200S, MULTISTRADA 1200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V631000·2015-10-08

    Navistar Recalls 2016 International Trucks Due to Engine Stalling Risk

    Navistar is recalling specific 2016 International trucks because the engine control module may short circuit, causing the engine to stall without warning and increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL DURASTAR, LONESTAR, PAYSTAR, PROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16006·2015-10-08

    Safety 1st Recalls Décor Wood Highchairs Due to Fall Hazard

    Safety 1st is recalling about 35,000 Décor Wood highchairs because children can remove the tray, posing a fall hazard. The company has received 68 reports of tray removal, including 11 injuries.

    Product
    Décor Wood Highchair
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1832-2015·2015-10-07

    Eagle Pharmacy Recalls Subpotent Lipo B Sterile Injection Vials

    Eagle Pharmacy is recalling 104 vials of Lipo B Sterile Injection due to trace amounts of methylcobalamin. The product was distributed in Alabama and Tennessee.

    Product
    LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy…
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-3248-2015·2015-10-07

    General Mills Recalls Cascadian Farm Organic Cut Green Beans for Listeria

    General Mills is recalling specific lots of Cascadian Farm Organic Cut Green Beans because one package tested positive for Listeria monocytogenes.

    Product
    Cascadian Farm Organic Cut Green Beans, Net Wt. 10 oz (284g) Keep Frozen.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2016·2015-10-07

    Biosense Webster Recalls SOUNDSTAR eco Diagnostic Ultrasound Catheters

    Biosense Webster is recalling SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters because the ultrasound image may disappear if the CARTO 3 system restarts during a pericardial effusion.

    Product
    SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2824-2015·2015-10-07

    Medtronic Navigated Solera Screwdrivers Recalled for Potential Tip Deformation

    Medtronic Navigation is recalling 2,346 Navigated Solera Screwdrivers used in spine surgery because specific use conditions may cause the tips to deform or break.

    Product
    P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2016·2015-10-07

    Biosense Webster Recalls Carto 3 EP Navigation System Due to Image Loss

    Biosense Webster is recalling the Carto 3 EP Navigation System because the ultrasound image may disappear during use, requiring a system restart.

    Product
    Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V630000·2015-10-07

    Volvo Recalls 2015-2016 Trucks for Headlight Intensity Defect

    Volvo is recalling 2015-2016 VAH and VHD trucks because some headlights do not meet federal intensity requirements, increasing crash risk.

    Product
    VOLVO — VOLVO VAH, VHD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3257-2015·2015-10-07

    KAL Amino Acid Complex Recalled for Undeclared Milk Allergen

    Nutraceutical International is recalling KAL Amino Acid Complex because the ingredient list does not explicitly state 'milk,' despite containing casein.

    Product
    KAL Brand Amino Acid Complex UPC 021245 51610 1, Product #51610
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0001-2016·2015-10-07

    US Endoscopy Recalls Histolock Resection Device Due to Sterility Concerns

    US Endoscopy Group Inc is recalling 41 units of the Histolock Resection Device because the company cannot assure the sterility of the affected lot.

    Product
    Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
    Category
    Medical Device
    Distribution
    9 states
  • HighCPSC·16701·2015-10-07

    BRP Recalls Youth Can-Am ATVs Due to Fuel Filter Fire Hazard

    BRP is recalling about 240 Youth Model Can-Am DS 90 and DS 90X ATVs because a fuel filter defect can cause leaks and fire. No injuries have been reported.

    Product
    Youth Model Can-Am all-terrain vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3247-2015·2015-10-07

    Russet House Recalls Frozen Sweet Potato Fries Due to Undeclared Gluten

    Russet House is recalling specific lots of America's Choice frozen sweet potato fries because they contain undeclared gluten. The product was distributed in six northeastern states.

    Product
    America's Choice Straight Cut Sweet Potatoes Fries, Frozen 539 g in plastic bag. Distributed by: ONPOINT Inc. Montvale, NJ. Product of Canada UPC: 7 54807 12025 5
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2823-2015·2015-10-07

    Medtronic Solera Screwdrivers Recalled for Tip Deformation Risk

    Medtronic Navigation is recalling 2,346 Solera screwdrivers used in spine surgery because specific conditions may cause the tips to deform or break.

    Product
    P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS. The Medtronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide