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.

1851–1875 of 52931

  • HighFDA (Devices)·Z-1465-2026·2026-03-04

    Medline dialysis maintenance kits recalled over Tego connector seal defects

    Medline is recalling seven convenience kits used for dialysis maintenance because the silicone seal on the Tego Connectors may dome or tear, which can occlude the fluid path.

    Product
    Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0351-2026·2026-03-04

    Bio Glo fluorescein strips 300-count recalled over sterility assurance failure

    Wizcure Pharmaa is recalling all lots of Bio Glo Fluorescein Sodium Ophthalmic Strips in 300-strip packs because the products were not manufactured in conformance with current 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 (Devices)·Z-1439-2026·2026-03-04

    Olympus resection inner sheath A22040A recalled over ceramic tip breakage

    Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040A, used in urologic applications, after complaints that the ceramic tip can break.

    Product
    Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2026·2026-03-04

    Medline dialysis dressing change kits recalled over connector seal defects

    Medline is recalling convenience kits containing Tego Connectors, sold as the Medline Dialysis Dressing Change kit, because the silicone seal may dome or tear and occlude the fluid path.

    Product
    Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2026·2026-03-04

    Medline nail kits recalled over saline wound wash sterility failure

    Medline is recalling Nail Kit convenience kits, model POD14214, because the manufacturer of the sterile saline wound wash they contain may not have met the required sterility assurance level.

    Product
    Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2026·2026-03-04

    Olympus 10 French sheath recalled over ceramic tip breakage complaints

    Olympus is recalling its Sheath, 10 Fr, model A37004A, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.

    Product
    Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0533-2026·2026-03-04

    Navitas Organics Organic Chia Seeds Recalled Over Salmonella Risk

    Navitas Organics is recalling organic chia seeds due to potential Salmonella contamination. The recall affects 114,432 units distributed across 26 U.S. states.

    Product
    NAVITAS ORGANICS ORGANIC CHIA SEEDS NET WT 8 OZ (227g) INGREDIENTS: CERTIFIED ORGANIC CHIA SEED (SALVIA HISPANICA). Product of Mexico/Argentina/Paraguay. Distributed by Navitas Organics Novato, CA USA 94949 UPC: 858847000284
    Category
    Food
    Distribution
    26 states
  • HighFDA (Drugs)·D-0352-2026·2026-03-04

    BioGlo fluorescein ophthalmic strips recalled over sterility assurance failure

    Wizcure Pharmaa is recalling all lots of BioGlo Fluorescein Sodium Ophthalmic Strips in 100-strip packs because the products were not manufactured in conformance with current good manufacturing practices.

    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-0346-2026·2026-03-04

    Vista Tears lubricant eye drops recalled over sterility assurance failure

    Wizcure Pharmaa is recalling all lots of Vista Tears Polyethylene Glycol 400 and Propylene Glycol eye drops because the products were not manufactured in conformance with current good manufacturing practices.

    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 (Devices)·Z-1447-2026·2026-03-04

    Olympus inner sheath model A2660 recalled over ceramic tip breakage

    Olympus is recalling its Inner Sheath, model A2660, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2026·2026-03-04

    Olympus resection sheath recalled after reports of ceramic tip breaking

    Olympus is recalling its Resection Sheath model A2666T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the sheath can break.

    Product
    Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2026·2026-03-04

    Olympus resection sheath recalled due to ceramic tip breakage

    Olympus is recalling 3,484 Resection Sheaths, Model A22041A, after receiving complaints that the ceramic tip can break during urologic procedures. The recall covers all lots distributed nationwide.

    Product
    Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2026·2026-03-04

    Medline apheresis and central line kits recalled over connector seal defects

    Medline is recalling Apheresis Subqport Access Kits and Central Line Insertion kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.

    Product
    Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2026·2026-03-04

    Olympus long inner sheath recalled after ceramic tip breakage complaints

    Olympus is recalling its Inner Sheath, Long, model WA22017A, used in urological and gynecological applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2026·2026-03-04

    Olympus Cystoscope Outer Sheath Recalled Due to Potential Device Tip Damage

    Olympus Corporation of the Americas is recalling Olympus Cystoscope Outer Sheath (Model WA22810A) because it may be incompatible with GreenLight Laser therapy, potentially damaging the device tip.

    Product
    Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0345-2026·2026-03-04

    Children's growth supplement recalled for containing undeclared ibutamoren

    Agebox is recalling iKids-Growth (Night Formula) 60-count bottles because the product was marketed without an approved NDA or ANDA and contains undeclared ibutamoren.

    Product
    Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2026·2026-03-04

    Hitachi Proton Beam Therapy System Recalled Due to Software Anomaly

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

    Product
    Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1433-2026·2026-03-04

    Medline trunk kits recalled over saline wound wash sterility failure

    Medline is recalling five Trunk Kit convenience kits because the manufacturer of the sterile saline wound wash they contain may not have met the required sterility assurance level.

    Product
    Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2026·2026-03-04

    Olympus Inner Sheath Medical Device Recall for Ceramic Tip Breakage

    Olympus recalls 91 units of its Inner Sheath Model A4741 medical device after receiving complaints of the ceramic tip breaking during gynecological endoscopic procedures.

    Product
    Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2026·2026-03-04

    Olympus Resection Sheath Model A2666 Recalled Due to Ceramic Tip Breakage

    Olympus recalls Model A2666 Resection Sheath for urologic use after receiving complaints of the ceramic tip breaking during procedures.

    Product
    Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2026·2026-03-04

    Olympus 24 French resection sheath recalled over ceramic tip breakage

    Olympus is recalling its Resection Sheath, 24 Fr, with Deflecting Obturator, model A22041T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.

    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-1436-2026·2026-03-04

    MRI LED Mobile Exam Light Battery REF SL-111 Recalled Due to Overheating

    MRIMed Inc. is recalling 314 MRI LED Mobile Exam Light Batteries due to battery component overheating while charging, which can cause internal component melting and smoke.

    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
  • HighFDA (Food)·H-0518-2026·2026-03-04

    Gerber arrowroot biscuits recalled over possible paper and plastic fragments

    Gerber is recalling Arrowroot Biscuits in a downstream recall because they contain an arrowroot flour ingredient recalled by the supplier over potential contamination with soft kraft paper and plastic bag pieces.

    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 (Food)·H-0523-2026·2026-03-04

    Chocolate pretzel candy recalled because contains statement omits peanut allergen

    J2C Hawaii is recalling Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel because the ingredients list declares peanut but the Contains statement does not.

    Product
    Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: ***INGREDIENTS: Sugar***Whey Powder, Nonfat Milk Powder, Soy Le
    Category
    Food
    Distribution
    1 state