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 →

351–375 of 26383

  • ModerateFDA (Devices)·Z-2099-2026·2026-05-13

    Medline Convenience Kits Recalled for Potential Sterilization Calibration Issues

    Medline Industries is recalling multiple convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. Approximately 5,497 units were affected and distributed nationwide.

    Product
    See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2115-2026·2026-05-13

    Medline Tracheostomy Convenience Kits Sterilization Calibration Recall

    Medline Industries is recalling certain tracheostomy convenience kits and related products due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2083-2026·2026-05-13

    One Step UTI in vitro diagnostic test recalled for missing FDA approval

    DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance or approval.

    Product
    One Step UTI in vitro diagnostic test REF: 3374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2026·2026-05-13

    Uric Acid in vitro diagnostic test distributed without FDA clearance

    DFI Co., Ltd. is recalling its Uric Acid in vitro diagnostic test (REF: 31H0P) because the devices were distributed without required FDA premarket clearance or approval.

    Product
    Uric Acid in vitro diagnostic test REF: 31H0P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2129-2026·2026-05-13

    Medline Surgical Gowns Sterilization Calibration Issues

    Medline Industries has recalled multiple lots of surgical gowns due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.

    Product
    See complete list in RES, exceeds character limit. Medline Surgical Gowns
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2073-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps 23ga Maculorhexis Forceps Recalled

    Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.

    Product
    DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2026·2026-05-13

    Duloxetine Delayed-Release Capsules Recalled for Impurity Above FDA Limit

    Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 60 mg (Lot PA07434, expiration May 2026) because testing found N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2082-2026·2026-05-13

    One Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance

    DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.

    Product
    One Step 10A in vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2084-2026·2026-05-13

    One Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance

    DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.

    Product
    One Step pH in vitro diagnostic test REF: 31I4P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2120-2026·2026-05-13

    Medline Burn Care Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries is recalling three burn care convenience kits because calibration issues with sterilization and packaging equipment could compromise their sterility assurance level.

    Product
    Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2026·2026-05-13

    ZENBONE Resorbable Bone Void Filler Recall Outside Specifications

    Orthorebirth Co Ltd is recalling ZENBONE resorbable bone void filler because the product falls outside standard specifications. The recall affects specific lot numbers distributed nationwide in California and Florida.

    Product
    ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Model DVF4034-25 Instruction Recall

    Katalyst Surgical, LLC is correcting instructions for DEX Ophthalmic Tissue Forceps, Model DVF4034-25. The company has issued a field safety corrective action for the product's instructions for use.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2026·2026-05-13

    Spacelabs SL Command Module patient monitor recall due to manufacturing defect

    Spacelabs Healthcare is recalling 57 SL Command Module (Model 91496) patient monitoring devices due to a manufacturing issue with the electrical leakage tester that could affect device safety and performance.

    Product
    Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2070-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps subject to IFU corrective action

    Katalyst Surgical is issuing a field safety corrective action for instructions for use (IFU) in DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH (Model DVF4005-25).

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2080-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Model DVF4034-27 Medical Device Recall

    Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps (Model DVF4034-27) distributed worldwide. The specific hazard or reason for the recall is not stated in the available source information.

    Product
    DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps recalled for instructions update

    Katalyst Surgical is issuing a Field Safety Corrective Action for DEX Ophthalmic Tissue Forceps (Model DVF4034-25-S) due to instructions-for-use (IFU) corrections needed.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2122-2026·2026-05-13

    Medline Convenience Kits sterilization calibration issue recalled

    Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2105-2026·2026-05-13

    Medline Admit Kit DYKA1343A Medical Device Recall

    Medline is recalling Admit Kits (Model DYKA1343A) due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2026·2026-05-13

    Duloxetine Delayed-Release Capsules Recalled for Impurity Above Limit

    Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules nationwide because the active ingredient contains N-nitroso-Duloxetine impurity above the FDA-recommended limit of 0.83 ppm.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2130-2026·2026-05-13

    Medline Surgical Packs recalled due to sterilization equipment calibration issues

    Medline Industries is recalling certain surgical packs because calibration issues with sterilization and packaging equipment may have affected sterility assurance. All recalled units were exposed to validated sterilization cycles but the calibration problems could impact sterility integrity.

    Product
    Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps subject to Field Safety Corrective Action

    Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for instructions for use (IFU) related to DEX Ophthalmic Tissue Forceps (Model DVF4005-23). The corrective action addresses a labeling issue in the product instructions.

    Product
    DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2075-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Field Safety Corrective Action Notice

    Katalyst Surgical is issuing a field safety corrective action for DEX Ophthalmic Tissue Forceps (Model DVF4019-25-S) due to instructions for use updates. The recall affects 645 units distributed nationwide in the US and internationally.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2026·2026-05-13

    QUCARE Total Cholesterol in vitro Diagnostic Test Recalled

    DFI Co., Ltd. is recalling QUCARE Total Cholesterol in vitro diagnostic test devices because they were distributed without required FDA premarket clearance or approval.

    Product
    QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2072-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Safety Corrective Action Recall

    Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps, 25ga Model DVF4016-25-S due to a field safety corrective action for instructions for use (IFU). The recall affects 90 units distributed nationwide in the US and internationally.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2117-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization calibration issues

    Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
    Category
    Medical Device
    Distribution
    Distributed nationwide