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.

12901–12925 of 22165

  • HighFDA (Devices)·Z-0720-2024·2024-01-24

    Field Cricothyrotomy Kit Recalled for Incompatible Endotracheal Tube Holder

    Sarnova HC is recalling the Curaplex Field Cric Kit due to an incompatible endotracheal tube holder that prevents practitioners from securing the tube during cricothyrotomy procedures. The recall affects 1,063 kits distributed nationwide.

    Product
    Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0752-2024·2024-01-24

    Herold's Salad Pasta Potpourri recalled for potential Listeria contamination

    Herold Salads, Inc. is recalling Pasta Potpourri salad due to potential Listeria monocytogenes contamination. Affected products in 1 lb, 2 lb, and 5 lb containers were distributed in Ohio, Pennsylvania, and Michigan.

    Product
    Herold's Salad - Pasta Potpourri packaged in 1lb, 2lb, and 5lb plastic containers
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0751-2024·2024-01-24

    Medical Device Calibration Serums Recalled Due to Instructional Transcription Errors

    Randox Laboratories has recalled multiple calibration serum products due to transcription errors in the Instructions for Use, which contain incorrect target values for several analytes.

    Product
    Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2024·2024-01-24

    Ultrasound Examination Table Recall Due to Backrest Platform Stress Fracture

    Oakworks Inc is recalling Ultrasound EA examination tables because the backrest platform can develop stress fractures, making the table inoperable in inclined positions. Approximately 104 units distributed nationwide are affected.

    Product
    Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0250-2024·2024-01-24

    Old Spice Pure Sport Deodorant Spray Recalled for Benzene Contamination Risk

    Procter & Gamble is recalling Old Spice Pure Sport Anti-Perspirant & Deodorant Spray (6.0 oz) due to potential benzene contamination risk from manufacturing facility CGMP deviations. All affected lots expire through September 2023.

    Product
    Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0247-2024·2024-01-24

    Secret OUTLAST Dry Spray Antiperspirant recalled for potential benzene contamination

    Procter & Gamble is recalling Secret OUTLAST Dry Spray Antiperspirant due to a manufacturing facility deviation where other lots were found contaminated with benzene. The recalled product was manufactured at the affected facility.

    Product
    Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Completely Clean, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-384-10, UPC 0 37000 74764 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2024·2024-01-24

    Maquet Prismalix OR Light Systems recalled due to fall hazard

    Getinge has recalled 236,793 Maquet Prismalix operating room light systems because the systems could potentially fall. The recall affects units distributed nationwide in the U.S. and globally.

    Product
    Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD56
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2024·2024-01-24

    Calibration Serum with Mis-assigned Alkaline Phosphatase Target

    Randox Calibration Serum Level 3 has an incorrect Alkaline Phosphatase target value (approximately 10% off) affecting clinical chemistry testing on RX Series instruments.

    Product
    Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2024·2024-01-24

    Maquet Volista OR Light Systems Recalled for Fall Hazard

    Getinge is recalling Maquet Volista OR light systems that may fall during use in operating rooms. Approximately 236,793 units are affected nationwide and globally.

    Product
    Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, RO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2024·2024-01-24

    Curaplex Cricothyrotomy Field Kit Recalled for Incompatible Tube Holder

    Sarnova HC recalls 15 Curaplex Cricothyrotomy Field Kits nationwide due to an incompatible endotracheal tube holder that prevents proper tube securement during cricothyrotomy procedures.

    Product
    Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
    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-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 - ARD56880
    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 MB3
    Category
    Medical Device
    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-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 (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 (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 (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-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-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 (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-0716-2024·2024-01-24

    Olympus Laser Fiber Stripper Recall Due to Sterilization Validation Gap

    Olympus recalls fiber stripper models sold before 2023 lacking validated sterilization instructions, creating a contamination risk when used on sterile medical fibers.

    Product
    Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
    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