The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 1691

  • HighFDA (Drugs)·D-0393-2026·2026-03-11

    Semaglutide injection vials recalled over lack of sterility assurance

    New Life Pharma is recalling one lot of Semaglutide Injection 2 mg sterile multi-dose vials for lack of assurance of sterility.

    Product
    Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0392-2026·2026-03-11

    Semaglutide injection multi-dose vials recalled over lack of sterility assurance

    New Life Pharma is recalling two lots of Semaglutide Injection 2 mg x 10 sterile multi-dose vials for lack of assurance of sterility.

    Product
    Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0395-2026·2026-03-11

    Tirzepatide injection 15 mg vials recalled over sterility assurance failure

    New Life Pharma is recalling one lot of Tirzepatide Injection 15 mg x 4 sterile multi-dose vials for lack of assurance of sterility.

    Product
    Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0394-2026·2026-03-11

    Tirzepatide injection vials recalled over lack of sterility assurance

    New Life Pharma is recalling one lot of Tirzepatide Injection 10 mg sterile multi-dose vials for lack of assurance of sterility.

    Product
    Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1434-2026·2026-03-04

    Medline Nail Kit Sterile Saline Wound Wash Recall

    Medline is recalling 8,773 NAIL KIT (Model DYKM1528) units because the sterile saline wound wash may not have been manufactured to the required sterility assurance level for sterile products.

    Product
    Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0339-2026·2026-03-04

    ADBRY Injection Drug Recall for Particulate Contamination

    LEO Pharma is recalling its ADBRY injection drug due to particulate matter (wool fiber) found in one unit, which may affect sterility. The recall covers 11,407 units distributed nationwide.

    Product
    ADBRY — ADBRY (TRALOKINUMAB-LDRM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2026·2026-03-04

    Sterile saline wound wash may not meet required sterility assurance level

    Medline is recalling Meijer Sterile Saline Wound Wash First Aid Cleansing Spray because the manufacturer may not have made the product to the minimum sterility assurance level required for sterile products.

    Product
    Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
    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 (Drugs)·D-0349-2026·2026-03-04

    Vista Gonio Eye Lubricant Recalled Due to Sterility Concerns

    Vista Gonio Eye Lubricant eye drops are being recalled because they may not be sterile. The product was not manufactured according to proper sterile drug-making standards.

    Product
    VISTA GONIO EYE LUBRICANT — VISTA GONIO EYE LUBRICANT (HYPROMELLOSE OPHTHALMIC SOLUTION)
    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 (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 (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-1431-2026·2026-03-04

    Medline Sterile Saline Wound Wash Recalled Due to Potential Sterility Issues

    Medline Industries, LP is recalling Medline Sterile Saline Wound Wash because the product may not meet required sterility assurance levels.

    Product
    Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0348-2026·2026-03-04

    Vista Meibo Tears eye drops recalled over sterility assurance failure

    Wizcure Pharmaa is recalling all lots of Vista Meibo Tears Propylene Glycol 0.6% eye drops because the products were not manufactured in conformance with current good manufacturing practices.

    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 (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-1420-2026·2026-02-25

    Medline Medical Device Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries is recalling 4,853 medical device kits due to potential sterility issues from equipment calibration problems during manufacturing.

    Product
    Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1390-2026·2026-02-25

    Medline Cardiac Surgical Convenience Kits Recalled Due to Sterility Calibration Issues

    Medline Industries is recalling cardiac surgical convenience kits due to sterilization equipment calibration issues that could affect device sterility assurance levels.

    Product
    Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1412-2026·2026-02-25

    Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues

    Medline Industries, LP is recalling specific Medline Convenience Kits (CHEST/BREAST-LF) because equipment calibration issues may have impacted the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2026·2026-02-25

    Medline Convenience Kits and CPNB Setup Trays Recalled Due to Sterilization Calibration Issues

    Medline Industries is recalling 779 units of convenience kits and setup trays due to potential sterility assurance issues from equipment calibration problems during manufacturing.

    Product
    Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2026·2026-02-25

    Medline Dental Packs Recalled Due to Potential Sterility Assurance Issues

    Medline Industries, LP is recalling certain Medline Convenience Kits (Dental Pack, Model DYNDA3003) because equipment calibration issues may have impacted the sterility of the products.

    Product
    Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1399-2026·2026-02-25

    Medline Medical Device Convenience Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries is recalling 154,427 medical device convenience kits due to calibration issues with sterilization equipment that could affect sterility assurance levels. No illnesses or injuries have been reported.

    Product
    Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC01054
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0094-2026·2025-10-15

    NAD+ injection recalled after elevated endotoxin levels found in one lot

    GenoGenix is recalling NAD+ for Injection at 100 mg/mL and 200 mg/mL from one lot for microbial contamination of sterile products, with elevated endotoxin levels.

    Product
    NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0477-2025·2025-07-02

    LX Bioboost Plus Pre-filled Syringe Recalled for Sterility Assurance

    Thrive Health Solutions is recalling LX Bioboost Plus pre-filled syringes due to lack of assurance of sterility. The affected product is a multi-ingredient injectable formulation distributed nationwide.

    Product
    LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inve
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1961-2025·2025-07-02

    MicroMyst Applicator recalled due to lack of sterility assurance

    Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.

    Product
    MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2025·2025-06-18

    Tecfen Medical 2.4mm Slit Knife Angled Ophthalmic Knife Recall

    Tecfen Medical is recalling its 2.4mm Slit Knife, Angled (Model QKN2461) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for controlled entry into the eye.

    Product
    Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
    Category
    Medical Device
    Distribution
    Distributed nationwide