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 →

1301–1325 of 26417

  • HighFDA (Devices)·Z-1440-2026·2026-03-04

    Olympus Resection Inner Sheath recalled for ceramic tip fractures

    Olympus Corporation of the Americas is recalling the Resection Inner Sheath (Model No. A22040T) used in urologic procedures due to complaints of ceramic tip breaking. Approximately 7,426 units were distributed nationwide.

    Product
    Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0348-2026·2026-03-04

    FDA Recalls Vista Meibo Tears Eye Drops for Lack of Sterility Assurance

    The FDA is recalling all lots of Vista Meibo Tears eye drops due to lack of sterility assurance from manufacturing non-conformance. Approximately 11,520 cartons were distributed nationwide in the USA.

    Product
    VISTA MEIBO TEARS PROPYLENE GLYCOL 0.6% W/V ADVANCED DRY EYE RELIEF LUBRICATING DROPS 10 ML — VISTA MEIBO TEARS PROPYLENE GLYCOL 0.6% W/V ADVANCED DRY EYE RELIEF LUBRICATING DROPS 10 ML (PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2026·2026-03-04

    Olympus Resection Sheath 8 mm Model A42011A Recalled for Ceramic Tip Breakage

    Olympus is recalling Resection Sheath Model A42011A due to complaints that the ceramic tip can break. The recall affects 899 units distributed nationwide in the United States.

    Product
    Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2026·2026-03-04

    Hitachi Proton Beam Therapy System software positioning anomaly

    Hitachi is recalling its Proton Beam Therapy System due to a software anomaly in the patient positioning system that may cause positional discrepancy during treatment.

    Product
    Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1441-2026·2026-03-04

    Olympus Resection Sheath Ceramic Tip Breaking Defect Recall

    Olympus Corporation is recalling the Resection Sheath, 24 Fr (Model A22041A) nationwide due to complaints that the ceramic tip can break during urologic procedures.

    Product
    Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0541-2026·2026-03-04

    Wellsley Farms Salmon Recalled for Listeria monocytogenes Contamination

    Wellsley Farms Farm-Raised Atlantic Salmon (32 oz) is being recalled due to potential contamination with Listeria monocytogenes. The affected product was distributed in Maryland; consumers should not consume it.

    Product
    Wellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1442-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Breaking

    Olympus Corporation is recalling the Resection Sheath Model A22041T due to complaints that the ceramic tip breaks. The device is used for urologic surgical procedures.

    Product
    Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2026·2026-03-04

    Olympus Resection Sheath Recalled for Ceramic Tip Breakage

    Olympus is recalling 118 Resection Sheaths (Model A22043A) distributed nationwide due to complaints of ceramic tip breakage during urologic procedures.

    Product
    Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0518-2026·2026-03-04

    Gerber Arrowroot Biscuits recalled nationwide for contaminated ingredient

    Gerber Arrowroot Biscuits (5.5 oz) are being recalled due to potential contamination with paper and plastic fragments in the arrowroot flour ingredient. The recall affects 258,474 cases nationwide and in Puerto Rico.

    Product
    Gerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0346-2026·2026-03-04

    Vista Tears Eye Drops Recalled for Lack of Sterile Manufacturing

    Vista Tears polyethylene glycol 400 and propylene glycol 0.3% eye drops are recalled nationwide due to failure to assure sterile manufacturing conditions. Consumers should stop using the product and contact their healthcare provider if they have experienced eye problems.

    Product
    Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0352-2026·2026-03-04

    BioGlo Fluorescein Sodium Ophthalmic Strips Recalled for Sterility Concerns

    The FDA has recalled 184,320 containers of BioGlo Fluorescein Sodium Ophthalmic Strips nationwide due to lack of sterility assurance resulting from manufacturing non-compliance. Consumers should stop using the product and consult a healthcare provider.

    Product
    BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0351-2026·2026-03-04

    Bio Glo Fluorescein Sodium Ophthalmic Strips Recalled Due to Sterility Failure

    Bio Glo Fluorescein Sodium Ophthalmic Strips are being recalled due to lack of assured sterility and failure to comply with good manufacturing practices.

    Product
    Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:[email protected], Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ven
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0349-2026·2026-03-04

    Eye Lubricant Recalled for Lack of Sterility Assurance Nationwide

    Vista Gonio Eye Lubricant is recalled nationwide due to lack of sterility assurance during manufacturing. The product was not made under proper conditions required for eye medications.

    Product
    VISTA GONIO EYE LUBRICANT — VISTA GONIO EYE LUBRICANT (HYPROMELLOSE OPHTHALMIC SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0344-2026·2026-03-04

    Agebox iKids-Growth capsules recalled for undeclared pharmaceutical ingredient

    Agebox is recalling Agebox iKids-Growth (Day Formula) capsules due to the presence of undeclared ibutamoren. The product was marketed without FDA approval.

    Product
    Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2026·2026-03-04

    Olympus Inner Sheath Model A2660 Recall Due to Ceramic Tip Fracture

    Olympus Corporation recalls the Inner Sheath Model A2660 used in urological endoscopic procedures due to complaints that the ceramic tip can break during use. No injuries have been reported.

    Product
    Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2026·2026-03-04

    Olympus Resection Sheath recalled for ceramic tip fracture

    Olympus is recalling Resection Sheath models A22014A and A22014T, used in urological endoscopy, after receiving complaints of ceramic tip breaking.

    Product
    Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0341-2026·2026-03-04

    AvKARE Recalls Amantadine HCl Capsules Over Failed Dissolution

    AvKARE is recalling Amantadine HCl capsules due to failed dissolution specifications that may affect medication effectiveness. Affected lot #49261 was distributed nationwide.

    Product
    AMANTADINE HCL — AMANTADINE HCL (AMANTADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0350-2026·2026-03-04

    Fluorescein Sodium Ophthalmic Strips Recalled for Sterility Assurance Defect

    Wizcure Pharmaa's Fluorescein Sodium Ophthalmic Strips have been recalled nationwide due to lack of assurance of sterility from manufacturing non-conformance with current good manufacturing practices. All lots are affected.

    Product
    C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS — C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2026·2026-03-04

    Olympus Resection Sheath ceramic tip may break during use

    Olympus is recalling Resection Sheath Model A2666 due to reports that the ceramic tip can break during urologic surgical procedures. The company has received complaints about this device failure.

    Product
    Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2026·2026-03-04

    Olympus Inner Sheath Recalled for Ceramic Tip Breakage in Medical Procedures

    Olympus is recalling the Inner Sheath, Long (Model WA22017A) used in urological and gynecological procedures due to complaints of ceramic tip breakage. Medical facilities should stop using the device and contact Olympus.

    Product
    Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0339-2026·2026-03-04

    Prescription injection recalled for particulate matter in sterile product

    LEO Pharma is recalling ADBRY (tralokinumab-ldrm) injectable medication due to wool fiber particles found in at least one unit, compromising sterility assurance of approximately 11,407 units distributed nationwide.

    Product
    ADBRY — ADBRY (TRALOKINUMAB-LDRM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2026·2026-03-04

    Medline Dialysis Kits Recalled for Defective Silicone Seals

    Medline is recalling 516 dialysis insertion kits due to silicone seal defects that may block fluid flow or cause therapy delays. Affected units risk allowing biological contamination or air to enter the body.

    Product
    Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Fracture Risk

    Olympus Corporation recalls 94 units of Model A37004A resection sheath used in urological procedures. Complaints indicate the ceramic tip can break during use.

    Product
    Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2026·2026-03-04

    Medline dialysis connector kits recalled for defective silicone seals

    Medline is recalling dialysis convenience kits because silicone seals on Tego Connectors may fail, potentially blocking fluid flow or allowing biological contaminants into the bloodstream. Affected lots should not be used.

    Product
    Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1436-2026·2026-03-04

    MRI Exam Light Batteries Recalled for Overheating and Fire Risk

    MRIMed is recalling 314 MRI LED Mobile Exam Light Batteries (Model SL-111) because they can overheat while charging, causing internal components to melt and generate smoke. Affected batteries were distributed nationwide and internationally.

    Product
    MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
    Category
    Medical Device
    Distribution
    Distributed nationwide