The Recall Desk

Hazard

Sterility Assurance recalls

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

What the numbers show

Total
663
Critical
0
Severe
261
Most recent
2026-08-26

Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) 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 assurance 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.

76–100 of 663

  • HighFDA (Drugs)·D-0433-2026·2026-04-15

    Fresenius sodium chloride 1,000 mL dialysis-supplied bags recalled over sterility

    Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by Fresenius Medical Care RTG, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0442-2026·2026-04-15

    Fagron vancomycin infusion bags recalled over sterility and detaching port part

    Fagron Sterile Services is recalling Vancomycin HCl 1 gram in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.

    Product
    Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0440-2026·2026-04-15

    Fagron vancomycin 1.25 gram bags recalled over sterility and detaching port part

    Fagron is recalling Vancomycin HCl 1.25 grams in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.

    Product
    Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0426-2026·2026-04-15

    Fresenius Kabi 100 mL sodium chloride freeflex bags recalled over sterility

    Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 100 mL freeflex bags under its own label, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0422-2026·2026-04-15

    Cipla lanreotide syringes with safety needle recalled over sterility assurance

    Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes supplied with a safety needle, citing lack of assurance of sterility. 54,583 syringes are affected.

    Product
    LANREOTIDE ACETATE — LANREOTIDE ACETATE (LANREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0441-2026·2026-04-15

    Fagron vancomycin 1.5 gram bags recalled over sterility and detaching port part

    Fagron is recalling Vancomycin HCl 1.5 grams in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.

    Product
    Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0423-2026·2026-04-15

    Cipla lanreotide prefilled syringes recalled over visual inspection deficiencies

    Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes for lack of assurance of sterility, following an FDA observation of deficiencies in visual inspection at the contract manufacturing site.

    Product
    LANREOTIDE ACETATE — LANREOTIDE ACETATE (LANREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0439-2026·2026-04-15

    Fagron norepinephrine 32 mg bags recalled over sterility and port part

    Fagron is recalling norepinephrine bitartrate 32 mg in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.

    Product
    norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0434-2026·2026-04-15

    Fresenius Kabi 1,000 mL sodium chloride bags recalled over sterility assurance

    Fresenius Kabi is recalling one batch of 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0430-2026·2026-04-15

    Fresenius Kabi 100 mL sodium chloride bags for BD recalled over sterility

    Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 100 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0427-2026·2026-04-15

    Fresenius Kabi 250 mL saline freeflex bags recalled over sterility assurance

    Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 250 mL freeflex bags under its own label, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0443-2026·2026-04-15

    Geri-Care artificial tears lubricant eye drops recalled over sterility assurance

    Preferred Pharmaceuticals is recalling six lots of Artificial Tears Lubricant Eye Drops manufactured by Geri-Care, citing lack of assurance of sterility. 720 bottles are affected.

    Product
    ARTIFICIAL TEARS — ARTIFICIAL TEARS (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0438-2026·2026-04-15

    Fagron norepinephrine infusion bags recalled over sterility and detaching port part

    Fagron is recalling norepinephrine bitartrate 16 mg in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.

    Product
    norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0409-2026·2026-04-08

    Quality Choice irritation relief eye drops recalled over sterility assurance

    Quality Choice Eye Drops Irritation Relief, containing tetrahydrozoline HCl and zinc sulfate, are being recalled for lack of assurance of sterility. 182,424 bottles are affected.

    Product
    QUALITY CHOICE EYE DROPS IRRITATION RELIEF — QUALITY CHOICE EYE DROPS IRRITATION RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2026·2026-02-25

    Robotic surgery kits recalled over sterilization equipment calibration issues

    Medline is recalling 7,725 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2026·2026-02-25

    General closure kits recalled over sterilization equipment calibration issues

    Medline is recalling 108 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2026·2026-02-25

    Universal and shoulder packs recalled over sterilization calibration issues

    Medline is recalling 193,157 units of surgical packs because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2026·2026-02-25

    Drape packs recalled over sterilization equipment calibration issues

    Medline is recalling 240 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2026·2026-02-25

    PICC line and code cart kits recalled over sterilization calibration issues

    Medline is recalling 5,346 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1410-2026·2026-02-25

    Admit kits recalled over sterilization equipment calibration issues

    Medline is recalling 1,070 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
    Category
    Medical Device
    Distribution
    Distributed nationwide