The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise 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.

826–850 of 2228

  • SevereFDA (Drugs)·D-0928-2018·2018-07-25

    Avella Recalls Ropivacaine Pumps Due to Potential Sterility Compromise

    Avella of Deer Valley is recalling 40 Ropivacaine OnQ pumps due to potential bag leakage that compromises sterility.

    Product
    0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0954-2018·2018-07-25

    Avella Recalls Morphine Syringes Due to Potential Sterility Compromise

    Avella of Deer Valley, Inc. is recalling 740 single-dose Morphine 150 mg syringes due to a lack of assurance of sterility caused by potential bag leakage.

    Product
    MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0948-2018·2018-07-25

    Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 40 bags of Heparin 1,000 Units in NS 250mL due to potential leakage that compromises sterility.

    Product
    HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0903-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0894-2018·2018-07-11

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Morphine Sulfate 1 mg/mL syringes due to a potential for leakage that compromises sterility.

    Product
    Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0905-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling 196 bags of Phenylephrine HCL 80mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0897-2018·2018-07-11

    SCA Pharmaceuticals Recalls Diltiazem HCL Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Diltiazem HCL sterile admixtures due to a potential for leakage that compromises sterility.

    Product
    Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0902-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL due to potential leakage that compromises sterility.

    Product
    Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0900-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0904-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL bags due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0901-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0885-2018·2018-06-27

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may leak, compromising sterility. The recall covers 267,288 bags distributed nationwide and in Canada.

    Product
    5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2018·2018-06-06

    Arrow PICC Set Recalled for Potential Sterility Compromise

    Arrow International Inc is recalling 416,055 ARROW PICC Sets because unsealed packaging may compromise product sterility.

    Product
    ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2018·2018-06-06

    Arrow PICC Sets Recalled Due to Potential Sterility Compromise

    Arrow International Inc is recalling 416,055 PICC sets because unsealed packaging may have compromised product sterility.

    Product
    ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 two-lumen central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2018·2018-06-06

    Arrow International Extension Line Slide Clamps Recalled for Sterility Concerns

    Arrow International is recalling Extension Line Slide Clamps because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Extension Line Slide Clamps; Product codes: SA-09847
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2018·2018-06-06

    Arrow International Recalls Pressure Injectable CVC Kits Due to Sterility Concerns

    Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2018·2018-06-06

    Arrow Multi-Lumen Central Venous Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2018·2018-06-06

    Arrow International Recalls Multi-Lumen CVC Kits Due to Packaging Issues

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kits because unsealed packaging may compromise sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling sterile needle counters because packaging seal creep may compromise sterility. The product is used to count surgical sharps.

    Product
    MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide