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.

926–950 of 1691

  • HighFDA (Devices)·Z-1330-2018·2018-04-18

    Arrow International Recalls Arterial Catheterization Kits Due to Sterility Concerns

    Arrow International Inc is recalling specific lots of arterial catheterization kits because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1243-2018·2018-04-04

    Stryker Recalls Break-Away Femoral Nozzles Due to Sterility Concerns

    Stryker is recalling 384 Break-Away Femoral Nozzles because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.

    Product
    Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1247-2018·2018-04-04

    Stryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns

    Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1253-2018·2018-04-04

    Stryker Recalls iVAS System Kits Due to Sterility Assurance Issues

    Stryker is recalling 51 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.

    Product
    10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1255-2018·2018-04-04

    Stryker Recalls Intramedullary Brushes Due to Sterility Assurance Failure

    Stryker is recalling 320 Intramedullary Brushes because bioburden levels exceeded acceptable rates, compromising sterility assurance.

    Product
    Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0991-2018·2018-03-21

    Alden Optical Recalls ASTERA Multifocal Toric Contact Lenses for Sterility Issues

    Alden Optical is recalling ASTERA Multifocal Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0984-2018·2018-03-21

    Alden Optical Recalls HP49 Sphere Daily Wear Soft Contact Lenses

    Alden Optical is recalling 23 units of HP49 Sphere Daily Wear Soft contact lenses because they lack sterility assurance.

    Product
    Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2018·2018-03-21

    Alden Optical Recalls NovaKone Toric Contact Lenses for Sterility Issues

    Alden Optical is recalling 33 units of NovaKone Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.

    Product
    NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not ap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 960 sterile 3.0 mm Reaming Rods because package seal defects may compromise sterility.

    Product
    3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0428-2018·2018-02-28

    Pharmedium Recalls Hydromorphone HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl in Sodium Chloride 0.9% due to a lack of sterility assurance.

    Product
    HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2018·2018-02-28

    Pharmedium Recalls Atropine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Atropine Sulfate Injection nationwide due to a lack of sterility assurance.

    Product
    Atropine Sulfate Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2018·2018-02-28

    Pharmedium Recalls Rocuronium Bromide Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all Rocuronium Bromide products due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Rocuronium Bromide in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0458-2018·2018-02-28

    Pharmedium Recalls Ropivacaine HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Ropivacaine HCl Injection in all strengths and packaging due to a lack of sterility assurance.

    Product
    Ropivacaine HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0432-2018·2018-02-28

    Pharmedium Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Ephedrine Sulfate in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.

    Product
    Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0454-2018·2018-02-28

    Pharmedium Recalls Glycopyrrolate Due to Lack of Sterility Assurance

    Pharmedium Services, LLC is recalling all strengths and packaging of Glycopyrrolate due to a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.

    Product
    Glycopyrrolate in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2018·2018-02-28

    Pharmedium Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Ephedrine Sulfate Injection due to a lack of sterility assurance.

    Product
    Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2018·2018-02-28

    Pharmedium Recalls All Nicardipine HCl Due to Sterility Assurance Issues

    Pharmedium Services, LLC is recalling all lots of Nicardipine HCl because the product lacks sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.

    Product
    Nicardipine HCl in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0438-2018·2018-02-28

    Pharmedium Recalls Lidocaine HCl Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all lots of Lidocaine HCl due to a lack of sterility assurance. The recall covers products distributed nationwide in the U.S.

    Product
    Lidocaine HCl in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0424-2018·2018-02-21

    PharMEDium Recalls Phenylephrine Injection Due to Sterility Assurance Failure

    PharMEDium Services, LLC is recalling 500 syringes of Phenylephrine HCl Injection due to a lack of assurance of sterility and potential endotoxin issues.

    Product
    100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0423-2018·2018-02-21

    PharMEDium Recalls Ropivacaine Cassettes Due to Sterility Assurance Failure

    PharMEDium Services, LLC is recalling 21 cassettes of 0.2% Ropivacaine HCI due to a failure to follow proper testing procedures, raising concerns about sterility and endotoxin levels.

    Product
    0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0159-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 130,740 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0157-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 29,232 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0160-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 96,828 bottles of sterile eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005587
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0144-2018·2018-01-03

    SSM St. Clare Recalls Phenylephrine Syringes Due to Sterility Concerns

    SSM St. Clare Health Center is recalling compounded phenylephrine syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.

    Product
    Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01
    Category
    Drug
    Distribution
    1 state