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.

25301–25325 of 50443

  • HighFDA (Devices)·Z-2055-2019·2019-07-31

    InfuTronix Nimbus Administration Set Recalled for Potential Tube Leakage

    InfuTronix LLC is recalling Nimbus Administration Sets due to a potential for tube leakage. The recall affects 10,800 units distributed in Massachusetts.

    Product
    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2025-2019·2019-07-31

    Siemens AXIOM Artis dFC X-ray Generator Recall for Power Supply Issue

    Siemens is recalling 19 AXIOM Artis dFC units because a power supply tolerance issue may cause generator failure, preventing X-ray procedures.

    Product
    AXIOM Artis dFC, Model Number 7727717
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2019·2019-07-31

    Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect

    Zyno Medical LLC is recalling administration sets where an inverted pinch clamp may cause blood to be drawn from the patient instead of delivering fluid.

    Product
    Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·19E052000·2019-07-31

    Vitro Recalls Aftermarket Rear Window Glass for Non-Compliant Fragment Size

    Vitro is recalling 47,366 aftermarket rear window glass units for various vehicles because improper tempering may result in large fragments that increase injury risk in a crash.

    Product
    VISIBILITY:GLASS, SIDE/REAR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2019·2019-07-31

    Spacelabs Smart Disclosure System Recalled for Patient Data Mismatch

    Spacelabs Healthcare is recalling the Smart Disclosure System because patient records were printed with waveforms from other patients.

    Product
    Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19E053000·2019-07-31

    Mekra Lang Recalls Truck Mirror Housings Due to Detaching Glass Risk

    Mekra Lang is recalling certain Main Mirror Housings for truck cabs because improper adhesive bonding may cause the mirror glass to detach, reducing driver visibility.

    Product
    VISIBILITY:GLASS, SIDE/REAR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1605-2019·2019-07-31

    Flowers Foods Recalls Hot Dog Buns Due to Potential Plastic Contamination

    Flowers Foods is recalling 46,122 packages of hot dog buns sold under multiple brands because they may contain small pieces of hard plastic.

    Product
    Hot Dog Buns sold under the brand names of: CLOVER VALLEY 8CT UPC 70210 00760 1; FAMILY STYLE 8CT UPC 70210 01297 1; FLOWERS RESTAURANT 12CT UPC 70210 00640 6, UPC 70210 00649 9 & UPC 70210 00964 3; FOOD DEPOT 8CT UPC 72250 02439 6; GREAT VALUE 8CT UPC 78742 09728 2; IDEAL 8CT…
    Category
    Food
    Distribution
    18 states
  • HighNHTSA·19V564000·2019-07-31

    Hino Recalls 2020 NJ8J, NE8J, and NV8J Trucks for Mirror Glass Defect

    Hino is recalling 1,531 model-year 2020 NJ8J, NE8J, and NV8J trucks because exterior mirror glass may detach, reducing driver visibility and increasing crash risk.

    Product
    HINO — HINO NJ8J, NE8J, NV8J
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 844,000 Sur-vet Needles because a loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2042-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2053-2019·2019-07-31

    MOOG Curlin Infusion Administration Set Recalled for Filter Leaks

    Zevex Incorporated is recalling MOOG Curlin Infusion Administration Sets because they leaked at the filter. The affected sterile sets were distributed to six US states.

    Product
    MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2041-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Concerns

    Cardinal Health is recalling Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1595-2019·2019-07-31

    FoodScience Recalls Mislabeled Omega 3 Dietary Supplement

    FoodScience Corporation is recalling 256 bottles of DaVinci Laboratories Omega 3-1,000 dietary supplements due to mislabeling and an undeclared allergen.

    Product
    DaVinci Laboratories of Vermont Omega 3-1,000 in a white bottle labeled as Dim Plex, 60 count UPC Code 026664273161
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-2003-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 563,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1996-2019·2019-07-31

    Stanley Healthcare Recalls Arial 54315 Network Manager Due to Outages

    Stanley Healthcare is recalling 137 Arial 54315 Network Managers because they caused outages in the Arial nurse call system.

    Product
    STANLEY Healthcare Arial 54315 Network Manager
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1599-2019·2019-07-31

    Flowers Foods Recalls Dinner Rolls Due to Potential Plastic Contamination

    Flowers Foods is recalling Laura Lynn and Wonder dinner rolls because they may contain small pieces of hard plastic introduced during production.

    Product
    Dinner Rolls sold under the brand names of Laura Lynn UPC 86854 06669 0 & Wonder 12 CT UPC 72250 07421 6 24 CT UPC 72250 01169 3
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-2004-2019·2019-07-31

    Terumo 18G Needles Recalled for Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 810,000 18G needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Needle, 18G x 1", Product Code NN1825R
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2009-2019·2019-07-31

    Philips BrightView SPECT Recalled for Uncommanded Handcontroller Motion

    Philips Medical Systems is recalling 696 BrightView SPECT units because the handcontroller may move spontaneously or continue moving after buttons are released.

    Product
    BrightView SPECT, Model Number 882480
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2022-2019·2019-07-31

    Siemens AXIOM Artis dBA X-ray Generator Recall for Power Supply Issue

    Siemens is recalling 85 AXIOM Artis dBA units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.

    Product
    AXIOM Artis dBA, Model Number 7555357
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2019·2019-07-31

    Cardinal Health Recalls Monoject Blunt Cannula Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling Monoject Blunt Cannulas due to a manufacturing defect that could compromise the product's sterility barrier.

    Product
    Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1514-2019·2019-07-31

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 139,680 containers of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for bags to leak.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1581-2019·2019-07-31

    Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Object

    Lupin Pharmaceuticals is recalling 11,832 bottles of Lisinopril and Hydrochlorothiazide tablets because a foreign tablet was found in the product.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide