The Recall Desk

Hazard

Sterility Failure recalls

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

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.

51–75 of 462

  • HighFDA (Drugs)·D-0477-2025·2025-07-02

    LX Bioboost Plus Pre-filled Syringes Recalled for Sterility Assurance Failure

    LX Bioboost Plus pre-filled syringes are being recalled because the manufacturer cannot assure the product meets sterility requirements. Consumers should stop using the product and consult their healthcare provider.

    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
  • HighFDA (Drugs)·D-0495-2025·2025-07-02

    Azelastine Hydrochloride Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Apotex Corp. is recalling 105,456 bottles of Azelastine Hydrochloride Ophthalmic Solution distributed nationwide due to lack of assurance of sterility. Patients should stop using the product and contact their healthcare provider.

    Product
    AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0486-2025·2025-07-02

    Tirzepatide and Cyanocobalamin Injectable Products Recalled for Sterility Concerns

    Thrive Health Solutions is recalling Tirzepatide/Cyanocobalamin injectable products due to lack of assurance of sterility. Lot C03125A (242 syringes) distributed nationwide should not be used.

    Product
    Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2025·2025-06-18

    Ophthalmic Slit Knives Recalled for Sterility Assurance Issue

    Tecfen Medical is recalling 47 ophthalmic slit knives (model QKN2808) due to inability to assure sterility. The products were distributed worldwide including the US, and are used in eye surgery.

    Product
    Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 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
  • HighFDA (Devices)·Z-1951-2025·2025-06-18

    Tecfen Medical 2.4mm Slit Knife Sterility Assurance Recall

    Tecfen Medical is recalling 115 units of the 2.4mm Slit Knife, Angled (Model QKN2461), an ophthalmic surgical instrument, due to sterility assurance concerns.

    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
  • HighFDA (Devices)·Z-1953-2025·2025-06-18

    Ophthalmic surgical knives recalled due to sterility assurance concerns

    Tecfen Medical is recalling 38 units of MVR Sideport Knives (Model QKN2312) due to sterility assurance concerns. The surgical instruments used in eye procedures may pose an infection risk if sterility cannot be assured.

    Product
    Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2025·2025-06-18

    Tecfen Medical ophthalmic slit knife recall due to sterility assurance

    Tecfen Medical is recalling its 3.2mm Slit Knife (model QKN3261), an ophthalmic surgical instrument, due to sterility assurance concerns. The recall affects 26 units distributed worldwide.

    Product
    Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to crea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0441-2025·2025-05-28

    Surgical skin antiseptic recalled due to open seal on sterile applicators

    ChloraPrep One-Step surgical antiseptic applicators are being recalled nationwide because some packages have open seals that could compromise sterility. Non-sterile applicators may pose a risk during surgical skin preparation.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0406-2025·2025-05-14

    Eye Lubricant Solution Recalled for Manufacturing Deviations and Sterility Concerns

    BRS Analytical Services is recalling Carboxymethylcellulose Sodium 0.5% ophthalmic solution nationwide due to manufacturing practice deviations and inability to assure sterility. Multiple lot numbers are affected.

    Product
    CARBOXYMETHYLCELLULOSE SODIUM — CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0367-2025·2025-04-30

    Prescription Haloperidol Decanoate Injection Recalled Due to Sterility Assurance Failure

    Amerisource Health Services LLC is recalling 2,110 vials of Haloperidol Decanoate injection because bacterial contamination was detected in manufacturing. The vials were distributed nationwide.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0370-2025·2025-04-30

    Glycopyrrolate injectable syringes recalled nationwide for sterility assurance failure

    Denver Solutions (Leiters Health) is recalling 170 Glycopyrrolate 1mg/5mL single-dose syringes nationwide due to leaking and damaged units compromising sterility.

    Product
    Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1528-2025·2025-04-23

    Ballard Closed Suction Catheters recalled due to lack of sterility assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters due to lack of sterility assurance, which poses a serious infection risk.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1525-2025·2025-04-23

    Ballard Closed Suction Catheters recalled for sterility assurance failure

    Avanos Medical is recalling 2080 units of Ballard Closed Suction Catheters (Model 2210-5) due to lack of sterility assurance, an FDA Class I recall affecting users worldwide.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1521-2025·2025-04-23

    Ballard Closed Suction Catheters recalled due to sterility assurance failure

    Avanos Medical recalls 1980 units of Ballard Closed Suction Catheters due to lack of sterility assurance. These neonatal and pediatric medical devices were distributed nationwide and internationally.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0357-2025·2025-04-16

    Haloperidol Decanoate injection recalled for sterility assurance failure

    Somerset Therapeutics recalls 23,960 vials of Haloperidol Decanoate Injection due to bacterial contamination identified in manufacturing process validation testing, indicating potential sterility compromise.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0358-2025·2025-04-16

    Haloperidol Decanoate Injection Recalled Due to Bacterial Contamination Risk

    Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to bacterial contamination detected during sterility validation testing. The contamination was found in media fill testing affecting 240 vials distributed nationwide.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0355-2025·2025-04-16

    Haloperidol Decanoate injection recalled due to sterility assurance failure

    Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to failed sterility testing. The recall affects 997 vials distributed nationwide with expiration date 07/2026.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1424-2025·2025-04-02

    Cysto Pack Procedure Trays Recalled Due to Sterility Assurance Issues

    American Contract Systems, Inc. is recalling 800 units of Cysto Pack procedure trays (Model BHCY31E) distributed in Arizona due to sterility assurance concerns.

    Product
    Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1425-2025·2025-04-02

    Lap Pack Convenience Kits Recalled for Sterility Assurance Concerns

    American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.

    Product
    Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1426-2025·2025-04-02

    Cardiac catheterization kit recalled due to sterility concerns

    American Contract Systems recalls 460 Cardiac Cath Lab Pack kits due to sterility assurance issues with procedure trays. Facilities should verify affected lots have been removed from clinical use.

    Product
    Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1130-2025·2025-02-19

    Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.

    Product
    Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2025·2025-02-19

    Cardinal Health Robotic Hysterectomy Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in surgical strips and patties. Endotoxins are bacterial contaminants that could cause complications during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2025·2025-02-05

    Medline Procedure Kits Recalled for Surgical Mask Bioburden Testing Failure

    Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.

    Product
    Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2025·2025-01-22

    Cardinal Health Fetal Surgery Kits Recalled for Endotoxin Contamination Risk

    Cardinal Health is recalling Presource fetal surgery kits due to potential endotoxin contamination in non-sterile surgical strips and patties, which could pose infection risk.

    Product
    Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.

    Product
    Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648
    Category
    Medical Device
    Distribution
    Distributed nationwide