The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

16426–16450 of 27263

  • HighFDA (Drugs)·D-0891-2023·2023-07-05

    Amphotericin B Liposome Injection Recalled for Subpotency Nationwide

    Sun Pharmaceutical recalled Amphotericin B Liposome for Injection due to subpotent drug content. The recall involved 12,960 vials distributed nationwide across the United States.

    Product
    Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2023·2023-07-05

    Knee Prosthesis Femoral Segment Recalled Due to Specification Compliance Issue

    Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-1012-2023·2023-07-05

    Rudolphs OnYums Onion Snack Rings recalled for undeclared wheat and artificial colors

    Rudolphs OnYums Onion Snack Rings are recalled for undeclared wheat and artificial colors. Consumers with wheat allergies should not consume this product.

    Product
    Rudolphs OnYums Onion Flavored Snack Rings 3 oz. UPC 0-24622-57106-9 packaged in metallized film bags, 15 bags per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2004-2023·2023-07-05

    PushTracker E2 watch app may crash, disabling wheelchair motor controls

    Permobil's PushTracker E2 watch controls wheelchair power assist motors. The application may crash when running multiple processes, causing the motor to keep running and preventing users from stopping it using normal controls.

    Product
    PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2020-2023·2023-07-05

    Orthopedic assembly screws with incorrect model number labeling and markings

    AEQUALIS FLEX REVIVE assembly screws were mislabeled during manufacturing, with some units marked as 0mm Standard actually being 0mm Short and vice versa. Surgeons must verify model numbers before use.

    Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2023·2023-07-05

    Design Options Epidural Anesthesia Kit Recalled for Incorrect Filter Straw

    B. Braun Medical is recalling Design Options Epidural Anesthesia Kits because certain units were assembled with an incorrect filter straw. The recall affects approximately 3,560 kits distributed nationwide.

    Product
    Design Options¿ / Epidural anesthesia kit (10 count carton)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1016-2023·2023-07-05

    Mott's Applesauce Recalled for Elevated Patulin Levels

    MOTTS LLP is recalling Mott's No Sugar Added Applesauce due to elevated patulin levels. The affected products have Best By dates of August 13-14, 2024, and were distributed across the U.S., Bermuda, and the Dominican Republic.

    Product
    Mott s no sugar added applesauce 6 pack 3.9 oz (111g) Containers 23.4 oz (666g). Individual units are packaged in plastic cups and placed in a cardboard sleeve of 6 sups with 12 sleeves to a case. Retail unit UPC is 14800000078 . Case label UPC is 10014800000075
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2010-2023·2023-07-05

    Limacorporate Prima TT Orthopedic Baseplate Recalled for Manufacturing Defect

    Limacorporate is recalling 13 units of the Prima TT Genoid Modular Reverse TT Baseplate due to a manufacturing issue that may cause peripheral holes to be out of specification. Healthcare facilities should contact the manufacturer.

    Product
    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2023·2023-07-05

    Integre Pro Laser Ophthalmoscope Systems: Risk of Unintended Laser Emission

    Ellex Medical is recalling certain Integre Pro laser ophthalmoscope systems because scattered laser radiation may unintentionally exit the device and be emitted from the objective lens, potentially exposing users' eyes to unexpected laser energy.

    Product
    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2023·2023-07-05

    Philips Respironics V60 Ventilator recalled for potential gas pathway contamination

    DRE Medical Group recalled 22 Philips Respironics V60 ventilators due to potential contamination in the gas pathway of retrofitted units. These devices may pose a serious health risk to patients.

    Product
    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2023-2023·2023-07-05

    Verigene nucleic acid test kits recalled for rare false-negative results

    Luminex Corporation recalls Verigene nucleic acid test kits that may rarely produce false-negative results due to hydrophobic properties in certain FLOQSwab lots. False-negative results could fail to detect enteric pathogens in patient samples.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2023·2023-07-05

    Knee prosthesis femoral segment recalled for specification non-compliance

    Waldemar Link is recalling 16 units of a knee prosthesis femoral segment due to specification non-compliance discovered through customer complaints. Patients and healthcare facilities should contact the manufacturer for guidance.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2019-2023·2023-07-05

    Orthopedic Assembly Screws Recalled Due to Labeling and Size Swap Error

    Tornier recalled 55 AEQUALIS FLEX REVIVE Assembly Screws (Model ARS655101) due to a labeling swap where Standard-length units were marked Short, and vice versa. This could result in implantation of the wrong screw size during orthopedic surgery.

    Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2023·2023-07-05

    VERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results

    Luminex is recalling the VERIGENE C. difficile diagnostic test due to the possibility of false-negative results in rare instances caused by hydrophobic characteristics in specific FLOQSwab lots.

    Product
    VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2023·2023-07-05

    Sertera 14 Gauge Biopsy Device: Needle Detachment Risk

    Hologic's Sertera 14 Gauge Biopsy Device may experience inner needle detachment or discharge during use, which could delay breast biopsy surgery. The company is recalling 756 units nationwide.

    Product
    Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2023·2023-07-05

    Voalte Patient Safety software may fail to alert caregivers of safety changes

    Baxter's Voalte Patient Safety software may permanently stop sending caregiver alerts for critical patient protocols like bed exit and siderail changes. Affected versions V4.0.000 through V4.0.401 are used with Centrella Beds.

    Product
    Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1301-2023·2023-07-05

    Sun Wave Brand Jelly Cups Recalled Due to Potential Choking Hazard

    Richin Trading Inc is recalling Sun Wave Brand Jelly Cups (Lychee Flavor) with multiple lot numbers due to a potential choking hazard. The recall affects 141,192 units distributed across 17 U.S. states.

    Product
    Sun Wave Brand Jelly Cup (Lychee Flavor); Made in Taiwan; Item Number 12152; UPC 715685121529; Net Weight 35.27 oz. (1000 g) Sun Wave Brand Jelly Cup (Lychee Flavor); Made in Taiwan; Item Number 12145; UPC 715685121451; Net Weight 52.91 oz. (1500 g)
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-2050-2023·2023-07-05

    Exactech Shoulder GPS Impactor Handle Recalled for Locking Mechanism Defect

    Exactech is recalling 250 units of its Shoulder GPS Impactor Handle due to a defect where the ball and spring in the locking mechanism can dislodge during disassembly or impaction. The defect could affect the device's function during surgical use.

    Product
    Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2008-2023·2023-07-05

    ILLUMISITE Platform Console Incorrectly Converted with Non-Supplied Power Components

    A Medtronic ILLUMISITE Platform Console was modified from 220-240VAC to 120VAC using non-supplied power cord and fuses, creating electrical hazards. One unit was distributed to Taiwan.

    Product
    Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2022-2023·2023-07-05

    Immunoassay Quality Control Material Recalled for Out-of-Range Values

    Randox Laboratories is recalling Immunoassay Premium Control Tri Level quality control kits due to out-of-range values that caused delays in test result reporting. The affected lot was distributed to five states and Puerto Rico.

    Product
    Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0882-2023·2023-07-05

    Homeopathic drug Bebelyn Colic Drops recalled for manufacturing deviations

    Bebelyn Colic Drops homeopathic remedy is recalled due to Current Good Manufacturing Practice deviations. Approximately 5,956 bottles were distributed nationwide.

    Product
    Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0887-2023·2023-07-05

    OTC Oral Care Rinse Recalled for Manufacturing Process Deviations

    StellaLife VEGA Oral Care Rinse (Coconut, Lot #2396) was recalled due to manufacturing process deviations. About 16,587 bottles were distributed nationwide.

    Product
    STELLALIFE VEGA ORAL CARE COCONUT — STELLALIFE VEGA ORAL CARE COCONUT (RISNE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2040-2023·2023-07-05

    Diagnostic Test Well Shows Inconsistent Results on Phadia 2500EE

    The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.

    Product
    EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac di
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0883-2023·2023-07-05

    Homeopathic diarrhea remedy recalled due to manufacturing control deviations

    Homeocare Laboratories is recalling Babelyn Diarrhea Drops due to manufacturing control (cGMP) deviations. The voluntary recall affects 5,957 bottles distributed nationwide.

    Product
    Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01
    Category
    Drug
    Distribution
    Distributed nationwide