The Recall Desk

Hazard

Sterility Failure recalls

1,693 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,693
Critical
12
Severe
938
Most recent
2026-09-30

Of the 1,693 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 938 (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.

901–925 of 1693

  • HighFDA (Devices)·Z-1592-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Exhaust Lines Due to Sterility Concerns

    Cook Inc. is recalling 760 StoneBreaker Exhaust Lines because the interior may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker C02 Cartridges Due to Sterility Concerns

    Cook Inc. is recalling 38,542 StoneBreaker C02 Cartridges because the interior may not be sterilized to the appropriate level when reprocessed.

    Product
    StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Probe Caps Due to Sterility Concerns

    Cook Inc. is recalling 370 StoneBreaker Probe Caps because the interior may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Pneumatic Lithotripter Due to Sterility Concerns

    Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter because the device may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0699-2018·2018-05-02

    Premier Pharmacy Labs Recalls Morphine Sulfate Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling specific lots of Morphine Sulfate Injection because routine testing of other lots detected microbial contamination risks.

    Product
    Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1532-2018·2018-05-02

    BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Issues

    Becton Dickinson is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.

    Product
    BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0701-2018·2018-05-02

    Premier Pharmacy Labs Recalls Hydromorphone Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 3,570 hydromorphone syringes because routine testing of other lots found microbial contamination risks.

    Product
    Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0702-2018·2018-05-02

    Premier Pharmacy Labs Recalls NeoStigmine Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling NeoStigmine Methylsulfate syringes because routine testing of other lots detected microbial contamination risks.

    Product
    NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2018·2018-05-02

    BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Failure

    Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.

    Product
    BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2018·2018-05-02

    Stryker T4 Zipper Toga Sterile Garment Recall for Layer Separation

    Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2018·2018-05-02

    BD Vacutainer Blood Collection Set Recalled for Sterility Assurance Failure

    Becton Dickinson is recalling BD Vacutainer Ultra Touch Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.

    Product
    BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0681-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Estradiol 55 mg pellets in Nevada due to a non-approved sterilization method.

    Product
    Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0670-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone and Anastrozole Pellets for Sterility Concerns

    Partell Specialty Pharmacy is recalling specific lots of Testosterone/Anastrozole pellets in Nevada due to a non-approved sterilization method.

    Product
    Testosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0667-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 50 mg pellets because they were sterilized using a non-approved method.

    Product
    Testosterone 50 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0663-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 100 mg pellets in Nevada because they were sterilized using a non-approved method.

    Product
    Testosterone 100 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0671-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone/Anastrozole pellets because a non-approved sterilization method was used, raising concerns about sterility assurance.

    Product
    Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0669-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 80 mg pellets in Nevada because they were sterilized using a non-approved method.

    Product
    Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0649-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Pregnenolone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Pregnenolone 100 mg pellets because they were sterilized using a non-approved method.

    Product
    Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0645-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Injectable Solution Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling TM #1 Injectable solution because a non-approved sterilization method was used. The product was distributed only in Nevada.

    Product
    TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0665-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 37.5 mg pellets because they were sterilized using a non-approved method.

    Product
    Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0641-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Methionine, Inositol, and Choline Vials

    Partell Specialty Pharmacy is recalling 11 vials of Methionine/Inositol/Choline in Nevada due to a non-approved sterilization method.

    Product
    Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0664-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 25 mg pellets because they were sterilized using a non-approved method.

    Product
    Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0673-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Estradiol 10 mg pellets in Nevada due to a non-approved sterilization method.

    Product
    Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • 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