The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

451–475 of 3531

  • ModerateFDA (Food)·F-0024-2025·2024-10-16

    Gelato Ice Cream Recalled for Possible Container Fragmentation

    ALCAS USA CORP. is recalling gelato ice cream packaged in compostable tubs due to possible fragmentation of the container material. Affected products were distributed in the USA, Cayman Islands, and Canada.

    Product
    Gelato ice cream packaged in Compostable Tubs which are labeled in part Vaschetta Accoppiata Compostabile . The gelato is packaged in four (4) sizes of Compostable Tubs: COMPOSTABLE YETI TUB 350 GR/ 500 CC (M) (16.90 fl. oz.) COMPOSTABLE YETI TUB 500 Gr/750 CC (25.36 fl. oz.)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0030-2025·2024-10-16

    Aligned Medical T and A Pack Recalled for Component Misuse Risk

    Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.

    Product
    Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2025·2024-10-16

    MAKO Integrated Cutting System Handpiece Recalled for Characterization Process Error

    Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.

    Product
    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0031-2025·2024-10-16

    Aligned Medical Tonsil Packs Recalled Due to Improper-Use Kit Component

    Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.

    Product
    Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2025·2024-10-16

    Inspire Respiratory Sensing Lead Model 4340 Serial Number Label Mismatch

    FDA recall of 152 Inspire Model 4340 Respiratory Sensing Lead units due to a labeling error—the serial number printed on the product box does not match the actual serial number of the device inside.

    Product
    Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2025·2024-10-16

    Aligned Medical Tonsil ENT Pack Recalled for Component Under Separate Recall

    Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.

    Product
    Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0002-2025·2024-10-09

    Ciclopirox Gel 0.77% Tubes Recalled Due to Broken Seals

    Glenmark Pharmaceuticals is recalling Ciclopirox Gel 0.77% tubes nationwide due to broken seals. The recall affects 11,568 tubes; no illnesses or injuries have been reported.

    Product
    Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured f
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3307-2024·2024-10-09

    DVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization

    The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.

    Product
    DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3306-2024·2024-10-09

    DVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization

    The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.

    Product
    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0006-2025·2024-10-09

    Ryaltris Nasal Spray Recalled for Clogged Dip Tube

    Ryaltris nasal spray is being recalled because the dip tube is clogged, preventing the spray from functioning. The recall affects 45,504 bottles distributed nationwide.

    Product
    RYALTRIS — RYALTRIS (OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3210-2024·2024-10-02

    AVS Anchor-C Cervical Cage Instructions for Use Labeling Correction

    Stryker Spine recalled the electronic Instructions for Use revision 5 for the AVS Anchor-C Cervical Cage System because specific indications language for the US and Canada was inadvertently removed.

    Product
    AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3220-2024·2024-10-02

    Karl Storz Hopkins Telescope 6 endoscope recalled for unapproved reprocessing instructions

    Karl Storz is recalling the Hopkins Telescope 6 endoscope because its Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 1,982 units distributed nationwide.

    Product
    Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3261-2024·2024-10-02

    Biodesign Inguinal Hernia Graft Recall Due to Premature Expiration

    Cook Biotech is recalling Biodesign Inguinal Hernia Graft units because products expire before their labeled expiration date, potentially affecting surgical outcomes.

    Product
    Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3214-2024·2024-10-02

    GE Centricity PACS Image Storage Failure When Maximum Identifiers Reached

    GE Healthcare Centricity PACS versions V2-V7 may fail to store medical images when reaching maximum unique image identifiers, potentially resulting in incomplete imaging studies. No injuries have been reported.

    Product
    GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0667-2024·2024-10-02

    Hand Sanitizer Manufacturer Recalls Product for Manufacturing Deviations

    EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel due to manufacturing deviations. The voluntary recall affects 120 bottles distributed to one North Carolina distributor.

    Product
    EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0662-2024·2024-10-02

    Sunscreen product recalled for microbial contamination nationwide

    SHEET SPF 30 Mineral sunscreen is being recalled for microbial contamination. The product was distributed nationwide.

    Product
    SHEET SPF 30 MINERAL — SHEET SPF 30 MINERAL (TITANIUM DIOXIDE, ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3189-2024·2024-10-02

    Stainless Steel Sims Uterine Sound Recalled for Incorrect Part Number

    CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound (Part Number 64-601) because some units were laser-marked with incorrect part numbers during manufacturing. No injuries have been reported.

    Product
    Stainless Steel Sims Uterine Sound, Part Number 64-601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3225-2024·2024-10-02

    Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.

    Product
    Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3196-2024·2024-10-02

    Philips Ingenia 3.0T CX MRI Machine Carrier Assembly Screws May Loosen

    Philips Ingenia 3.0T CX MRI machines may have loose screws in the RF carrier assembly that could protrude and interfere with the tabletop mechanism, potentially delaying patient scans.

    Product
    Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24378·2024-09-26

    Liberty Hardware Multi-Grip Tub Safety Bars Recalled for Fall Hazard

    Liberty Hardware is recalling about 174,500 Multi-Grip Tub Safety Bars because plastic grip pads can become dislodged on tapered tubs, making the bars unstable and creating a fall hazard. One minor fall injury has been reported.

    Product
    Multi-Grip Tub Safety Bars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3183-2024·2024-09-25

    Emergency Hypothermia Management Kits Recalled for Incorrect Expiration Dates

    Safeguard US Operating LLC is recalling 567 units of HAWK warming kits due to incorrect expiration date labeling. The kits were distributed nationwide in 16 states.

    Product
    Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3154-2024·2024-09-25

    McKesson 60 mL Syringes Recalled Lacking FDA Clearance

    Cypress Medical Products is recalling McKesson 60 mL syringes that lack FDA clearance. The syringes were inadvertently shipped from a distribution center due to an order processing error and were on quarantine.

    Product
    General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3184-2024·2024-09-25

    BinaxNOW Respiratory Strep A Test Kits Shipped to Unlicensed Purchasers

    Cypress Medical Products is recalling BinaxNOW Respiratory Strep A Test Kits due to an inventory system error that resulted in shipment to customers without proper licensing to purchase medical devices.

    Product
    BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3162-2024·2024-09-25

    Marodyne-LiV vibration exerciser recalled for power supply voltage defect

    Marodyne-LiV low-intensity vibration exercisers with certain serial numbers are recalled due to a power supply voltage drop that unexpectedly interrupts treatment. Manual activation is required to restart the device.

    Product
    Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3186-2024·2024-09-25

    VariSoft Infusion Sets recalled due to incorrect secondary packaging

    Unomedical A/S is recalling specific VariSoft Infusion Sets packaged in boxes incorrectly branded as 'Trusteel Infusion Set' instead of 'VariSoft.' No injuries or illnesses have been reported.

    Product
    VariSoft Infusion Set, Single Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide