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.

10376–10400 of 53042

  • HighFDA (Devices)·Z-0757-2024·2024-01-24

    Maquet PowerLEDII Operating Room Light System Recalled for Fall Risk

    Getinge Usa Sales Inc is recalling Maquet PowerLEDII OR light systems due to a potential for the light to fall in the operating room. No injuries have been reported.

    Product
    Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0713-2024·2024-01-24

    Deli Carolina Style Mustard BBQ Sauce recalled for undeclared fish allergen

    Ventura Foods is recalling Deli Carolina Style Mustard BBQ Sauce for undeclared fish (anchovy) allergen. If you have a fish allergy, do not consume this product.

    Product
    DELI CAROLINA STYLE MUSTARD BBQ SAUCE, 2 oz (57g), plastic cup, 96 cups/case, store in ambient temperatures
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0735-2024·2024-01-24

    Intraocular Lens Cylinder Axis Marks Out of Specification

    Johnson & Johnson is recalling TECNIS Toric II intraocular lenses distributed in Japan. The cylinder axis marks do not meet product specifications and could affect vision correction.

    Product
    TECNIS Toric II OptiBlue IOL Models ZCW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0724-2024·2024-01-24

    Full Circle Organic Chai Tea Latte Recalled for Potential Microbial Contamination

    TreeHouse Foods is recalling Full Circle 32oz Organic Chai Tea Latte (Lot 98E03223) due to potential microbial contamination. The product was distributed across the U.S., and consumers should not consume it.

    Product
    Full Circle, 32oz Organic Chai Tea Latte
    Category
    Food
    Distribution
    37 states
  • HighFDA (Drugs)·D-0227-2024·2024-01-24

    Magnesium Citrate Laxative Oral Solution Recalled for Bacterial Contamination

    Good Neighbor Pharmacy brand Magnesium Citrate laxative is being recalled due to Acetobacter nitrogenifigens bacterial contamination. The FDA recommends consumers stop using the product.

    Product
    MAGNESIUM CITRATE — MAGNESIUM CITRATE (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0725-2024·2024-01-24

    Central Market Organic Chicken Broth Concentrate Recalled for Microbial Contamination

    TreeHouse Foods, Inc. is recalling Central Market 16oz Organic Low Sodium Chicken Broth Concentrate due to potential microbial contamination. The affected product has been distributed to 41 states.

    Product
    Central Market 16oz Organic Low Sodium Chicken Broth Concentrate
    Category
    Food
    Distribution
    37 states
  • HighFDA (Drugs)·D-0249-2024·2024-01-24

    Old Spice Pure Sport Gift Set Recalled for Benzene Contamination Risk

    Procter & Gamble is recalling Old Spice Pure Sport 2021 Gift Sets due to benzene contamination at the manufacturing facility. No illnesses have been reported.

    Product
    Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash 18 Fl Oz (532 mL), 2-in-1 Shampoo & Conditioner 13.5 Fl Oz (400 mL), and Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2024·2024-01-24

    Philips Spectral CT 7500 Recalled for Multiple Software Issues Affecting Functionality

    Philips is recalling 197 Spectral CT 7500 computed tomography systems due to multiple software issues affecting device functionality. The devices were distributed nationwide and internationally.

    Product
    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2024·2024-01-24

    GammaPod Radiation Treatment Planning System Software Error Allows Wrong Imaging Structures

    Xcision Medical Systems recalled 4 GammaPod Treatment Planning Systems due to a software error that allows incorrect radiation structures from previous CT scans to be imported and selected, potentially affecting treatment planning accuracy.

    Product
    GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2024·2024-01-24

    Medical Device Stopcock Recalled Due to O-Ring Seal Defect

    Smiths Medical Asd Inc is recalling approximately 31,685 Stopcock Left Rotator devices due to oversized O-rings that may compromise seal integrity. The defect may cause medication leaks, potentially resulting in under-infusion during treatment.

    Product
    1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2024·2024-01-24

    Smiths Medical Injection Line Rotating Adapters Recalled for Seal Defect

    Smiths Medical is recalling specific injection line rotating adapters due to a manufacturing defect causing oversized O-rings that may lead to inadequate seal integrity and medication under-infusion.

    Product
    48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2024·2024-01-24

    Maquet Orchide OR Light Systems recalled due to fall risk

    Getinge USA is recalling Maquet Orchide OR Light Systems due to a potential for light fixtures to fall in the operating room. No injuries have been reported.

    Product
    Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0736-2024·2024-01-24

    Reduced Sodium Chicken Broth Recalled for Potential Microbial Contamination

    TreeHouse Foods is recalling reduced sodium chicken broth sold under WinCo, HEB Select Ingredients, and Signature Select brands due to potential microbial contamination. Approximately 439,240 cases distributed to 37 states are affected.

    Product
    Reduced Sodium Chicken Broth labeled under: WinCo, 32oz Reduced Sodium Chicken Broth HEB Select Ingredients, 32oz Reduced Sodium Chicken Broth Signature Select, 48oz Reduced Sodium Chicken Broth Signature Select, 32oz Reduced Sodium Chicken Broth HEB Select Ingredients, 48oz…
    Category
    Food
    Distribution
    37 states
  • HighFDA (Drugs)·D-0256-2024·2024-01-24

    Secret Dry Spray Antiperspirant Recalled Over Manufacturing Facility Defect

    Secret Dry Spray antiperspirant is being recalled due to CGMP violations at the manufacturing facility where other lots were found contaminated with benzene. No illnesses have been reported.

    Product
    Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-380-10, UPC 0 37000 79884 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0642-2024·2024-01-24

    ExcelsiusGPS surgical navigation system calibration error may cause device misplacement

    Globus Medical is recalling the ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit due to a calibration error that may cause inaccurate navigation and device misplacement during surgery. Nine units are distributed across select US states and internationally.

    Product
    ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0718-2024·2024-01-24

    SOLTIVE SuperPulsed Laser Fibers May Have Breached Sterile Pouch Seals

    Olympus Corporation recalls 179 SOLTIVE SuperPulsed Laser Fibers due to potentially breached sterile pouch seals that could cause procedure delays or patient infections if not detected before use.

    Product
    SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0752-2024·2024-01-24

    Medical Diagnostic Calibration Serum Recalled for Positive Measurement Bias

    Randox Laboratories is recalling Calibration Serum Level 3 (CAL2351) distributed in the US and Puerto Rico because it exhibits a positive bias in CK Total measurements on RX Series instruments, potentially affecting test accuracy by up to 13%.

    Product
    Calibration Serum Level 3 CAL2351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2024·2024-01-24

    Maquet PowerLED and PowerLED300 Surgical Light Systems Fall Hazard Recall

    Getinge recalls 236,793 units of Maquet PowerLED and PowerLED300 operating room light systems due to a potential for the light to fall in the operating room.

    Product
    Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS MB3 - ARDINT059003A, EPS MB3 - ARDINT059003C, EPS MB3 TR - ARDINT059001A, EPS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0712-2024·2024-01-24

    Wellsley Farms Assorted Mini Quiches Recalled for Possible Aluminum Foreign Material

    The Fillo Factory Inc. is recalling Wellsley Farms Assorted Mini Quiches due to possible aluminum foreign material contamination. Approximately 3,412 retail units distributed to stores across multiple states are affected.

    Product
    Wellsley Farms Assorted Mini Quiches NET WT 36 OZ (2LB 4 OZ) 1.02kb Keep Frozen UPC: 8867002630. Packaged in plastic trays in a cardboard box. 2 sealed trays in a box, 10 boxes per case
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0231-2024·2024-01-24

    Magnesium Citrate Oral Solution Recalled for Bacterial Contamination

    Pharma Nobis LLC is recalling 7,404 bottles of Freskaro Magnesium Citrate Oral Solution nationwide due to the presence of Acetobacter nitrogenifigens bacteria.

    Product
    MAGNESIUM CITRATE — MAGNESIUM CITRATE (FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0720-2024·2024-01-24

    Member's Mark Mild Cheddar Shredded Cheese Recalled for Glove Remnants

    Member's Mark Mild Cheddar shredded cheese is being recalled due to possible glove remnants. The recall affects specific lots distributed to Illinois, Indiana, Missouri, and Ohio.

    Product
    Member's Mark - Mild Cheddar Fancy (Fine) Shredded Cheese packaged in 5lbs, 8 packages per case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0771-2024·2024-01-24

    Maquet Operating Room Light Systems Recalled Due to Fall Hazard

    Getinge Usa Sales Inc is recalling 236,793 Maquet operating room light systems nationwide due to a potential for the light system to fall, posing a safety risk to surgical patients and staff.

    Product
    Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0729-2024·2024-01-24

    Vegetable Broth Recalled for Potential Microbial Contamination

    TreeHouse Foods is recalling vegetable broth sold under Essential Everyday, HEB Select Ingredients, and Chef's Cupboard brands due to potential microbial contamination. Products distributed to 37 states.

    Product
    Vegetable Broth sold under: Essential Every day, 32oz Vegetable Broth, HEB Select Ingredients, 32oz Vegetable Broth Chef's Cupboard, 32oz Vegetable Stock
    Category
    Food
    Distribution
    37 states