The Recall Desk

Hazard

Sterility Issue recalls

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

What the numbers show

Total
8
Critical
0
Severe
1
Most recent
2026-04-15

Of the 8 sterility issue recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (13%) 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 issue 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.

1–8 of 8

  • HighFDA (Devices)·Z-0168-2025·2024-10-30

    Medline IV TEAM PICC Kits Recalled Due to Potential Non-Sterile Product

    Medline IV TEAM PICC medical procedure kits may contain non-sterile product if the breather pouch vendor seal has been opened. The recall affects 120 units distributed worldwide including the US, Canada, and Panama.

    Product
    Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2023·2023-02-22

    Surgical convenience kits recalled due to sterile packaging failure

    Medline Industries is recalling 138 surgical convenience kits nationwide because the outer packaging does not maintain sterility. Only the contents inside the kit wrapper are sterile, creating a contamination risk.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0233-2023·2023-02-01

    Pharmacy Innovations Progesterone Injectable Vial Recalled for Sterility Concerns

    Pharmacy Innovations is recalling PROGESTERONE-GS OIL 100MG/ML injectable vials distributed nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2023·2022-11-23

    Teleflex RUSCH Pocket Pac Urinary Catheter Kit Recalled for Sterility Concerns

    Teleflex Medical recalled approximately 7,200 RUSCH Pocket Pac i.c. urinary catheter kits due to potential sterility issues. Patients should contact their healthcare provider and discontinue use.

    Product
    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Drugs)·D-1198-2022·2022-07-20

    Calcium Chloride Injectable Solution Recalled Due to Sterility Assurance Concerns

    TMC Acquisition LLC is recalling Calcium Chloride Preservative Free injectable solution in 5 mL and 30 mL vials due to lack of assurance of sterility. The recall affects 138 vials distributed nationwide.

    Product
    Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2922-2020·2020-09-09

    Teleflex Pleur-evac Thoracic Catheters Recalled for Potential Sterility Issue

    Teleflex Medical Inc is recalling Pleur-evac Thoracic Catheters due to a potential sterility issue. The recall affects 700 units distributed across 25 US states.

    Product
    Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.
    Category
    Medical Device
    Distribution
    27 states