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.

36226–36250 of 50504

  • HighFDA (Devices)·Z-1261-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling 400 units of I.V. infusion administration sets because the connection between the drip chamber and ChemoLock port may develop a leak.

    Product
    31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1294-2016·2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices due to unspecified product defects.

    Product
    Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Food)·F-0815-2016·2016-04-06

    Ventura Foods Recalls Cooking Oil Jugs Due to Plastic Contamination

    Ventura Foods is recalling 35 lb. jugs of cooking oil because plastic fragments may be present due to a manufacturing defect in the jugs.

    Product
    18168-BLN : Brilliance Clear Premium Frying Oil 35 lb. ; 16763-MFY : Mel-Fry Essential High Performance Liquid Frying Oil 35 lb. ; 16502-MFY : Mel-Fry Premium High Performance Liquid Frying Oil 35 lb. ;
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1284-2016·2016-04-06

    Siemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee/zeego angiography systems because a cooling system leak could cause equipment failure.

    Product
    AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Undersleeves and Walkers

    Ossur Americas is recalling various medical devices, including knee undersleeves and walkers, due to a defect described in the source text.

    Product
    Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1251-2016·2016-04-06

    IMCO Conforming Stretch Gauze Bandages Recalled for Sterility Failure

    Amd Ritmed is recalling IMCO Conforming Stretch Gauze Bandages because FDA testing found the product was not sterile and tested positive for Bacillus bacteria.

    Product
    IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1256-2016·2016-04-06

    ICU Medical Recalls IV Infusion Sets with Potential ChemoLock Port Leak

    ICU Medical is recalling specific IV infusion administration sets because the connection between the drip chamber or bag spike and the ChemoLock port may develop a leak.

    Product
    30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1248-2016·2016-04-06

    Maquet Recalls Cardiosave Hybrid and Rescue IABP Devices

    Maquet is recalling Cardiosave Hybrid and Rescue IABP devices because the scroll compressor may not meet specifications for output pressure or vacuum at specific flow rates.

    Product
    Cardiosave Hybrid and rescue IABP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2016·2016-04-06

    ICU Medical Recalls IV Administration Sets with ChemoLock Port Leak Risk

    ICU Medical is recalling specific IV administration sets because a connection may develop a leak. The sets are distributed in the US and several international locations.

    Product
    74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1276-2016·2016-04-06

    Roche Estradiol III Assay Recalled Due to Fulvestrant Cross-Reactivity

    Roche is recalling the Estradiol III assay because fulvestrant treatment causes falsely elevated estradiol results, potentially leading to incorrect patient management.

    Product
    Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2016·2016-04-06

    Ossur Recalls Rebound Diabetic Walkers and Other Medical Devices

    Ossur Americas is recalling Rebound Diabetic Walkers and other medical devices due to a defect described as 'the p'.

    Product
    Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1312-2016·2016-04-06

    Synthes Recalls 4.5 mm LCP Proximal Tibia Plate Systems

    Synthes (USA) Products LLC is voluntarily recalling 42 lots of 4.5 mm LCP Proximal Tibia Plate Systems due to a medical device defect.

    Product
    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Braces and Walkers

    Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.

    Product
    Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Food)·F-0809-2016·2016-04-06

    Linda's Salsa Hot Recalled Due to Insanitary Production Conditions

    Flowers For Less is recalling 71 units of Linda's Salsa Hot in 16 oz. glass jars because they were produced under insanitary conditions following a security breach.

    Product
    Linda's Salsa Hot in 16 oz. glass jars
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1255-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling 215 I.V. infusion administration sets because a connection may develop a leak.

    Product
    30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1287-2016·2016-04-06

    Ossur Recalls NecLoc Extrication Collars and Other Medical Devices

    Ossur Americas is recalling NecLoc Extrication Collars and other medical devices due to a defect described as 'the p'.

    Product
    NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1307-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16E029000·2016-04-06

    Hale Portable Pumps Recalled for Mislabeled Warning Light

    Hale Products Inc. is recalling portable pumps with Yanmar diesel engines due to a mislabeled dashboard warning light that could hinder fire suppression.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Back Support Suspenders

    Ossur Americas is recalling various medical devices, including back support suspenders, due to a defect described in the source text.

    Product
    Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1289-2016·2016-04-06

    Ossur Recalls Rebound Cartilage Knee Braces and Other Medical Devices

    Ossur Americas is recalling Rebound Cartilage knee braces and other medical devices due to a defect described in the source text.

    Product
    Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1310-2016·2016-04-06

    Siemens AXIOM Artis X-Ray Systems Recalled for Cooling System Leak

    Siemens is recalling 1,757 AXIOM Artis angiography systems because a possible leak in the cooling system could allow fluids to seep into the equipment cabinet.

    Product
    AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2016·2016-04-06

    Siemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee/zeego angiography systems because a cooling system leak could cause equipment failure.

    Product
    AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide