The Recall Desk

Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,383
Critical
1
Severe
2,113
Most recent
2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (89%) 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 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.

751–775 of 2383

  • HighFDA (Devices)·Z-1323-2018·2018-04-18

    Arrow MAC Two-Lumen Central Venous Access Kits Recalled for Sterility Concerns

    Arrow International is recalling specific lots of MAC Two-Lumen Central Venous Access Kits because the seals may be incomplete, preventing a guarantee of sterility.

    Product
    (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1251-2018·2018-04-04

    Stryker Recalls 30 Revolution 90 Degree Tibial Nozzles for Sterility Issues

    Stryker is recalling 30 units of the Revolution 90 Degree Tibial Nozzle because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1254-2018·2018-04-04

    Stryker iVAS System Kits Recalled for Sterility Assurance Issues

    Stryker is recalling 504 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

    Product
    1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1250-2018·2018-04-04

    Stryker AutoPlex Bone Cement Recalled for Sterility Assurance Issues

    Stryker is recalling AutoPlex bone cement systems because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1248-2018·2018-04-04

    Stryker Recalls Advanced Cement Mixing Kits Due to Sterility Concerns

    Stryker is recalling 1,542 Advanced Cement Mixing Kits because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0440-2018·2018-02-28

    Pharmedium Recalls Potassium Chloride Infusions Due to Sterility Concerns

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

    Product
    Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2018·2018-02-28

    Pharmedium Recalls Methadone HCl Injection Due to Sterility Concerns

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

    Product
    Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0422-2018·2018-02-21

    PharMEDium Recalls Oxytocin Injection Bags Due to Sterility Concerns

    PharMEDium Services, LLC is recalling 24 bags of Oxytocin Injection due to a lack of assurance of sterility and potential endotoxin issues.

    Product
    15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0134-2018·2018-01-03

    Simple Diagnostics Recalls Alcohol Prep Pads Due to Sterility Concerns

    Simple Diagnostics is recalling 150,250 alcohol prep pads because the company cannot ensure they are sterile and due to cGMP deviations.

    Product
    Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0139-2018·2018-01-03

    SSM St. Clare Recalls Hydromorphone PCA Cartridges Due to Sterility Concerns

    SSM St. Clare Health Center is recalling specific lots of compounded Hydromorphone PCA cartridges due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.

    Product
    HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0145-2018·2018-01-03

    SSM St. Clare Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    SSM St. Clare Health Center is recalling specific lots of compounded succinylcholine chloride syringes because microbial growth was detected during a routine manufacturing simulation.

    Product
    Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0062-2018·2017-11-08

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Injection Bags

    SCA Pharmaceuticals is recalling 116 bags of fentanyl and bupivacaine injection due to a lack of assurance of sterility.

    Product
    fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0067-2018·2017-11-08

    SCA Pharmaceuticals Recalls Calcium Gluconate Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 76 bags of Calcium Gluconate 2 g in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0066-2018·2017-11-08

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,221 syringes of Phenylephrine HCl 100 mcg/mL due to a lack of assurance of sterility.

    Product
    PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0060-2018·2017-11-08

    SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 128 syringes of Hydromorphone HCL 1 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0061-2018·2017-11-08

    SCA Pharmaceuticals Recalls Hydromorphone and Bupivacaine Injection Bags

    SCA Pharmaceuticals is recalling 60 bags of Hydromorphone and Bupivacaine injection due to a lack of assurance of sterility.

    Product
    HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0063-2018·2017-11-08

    SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine CADD Cassettes

    SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine CADD cassettes due to a lack of assurance of sterility.

    Product
    fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0068-2018·2017-11-08

    SCA Pharmaceuticals Recalls Rocuronium Bromide Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 487 syringes of Rocuronium Bromide 10 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0064-2018·2017-11-08

    SCA Pharmaceuticals Recalls Morphine Sulfate Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection due to a lack of assurance of sterility.

    Product
    morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0025-2018·2017-11-01

    Banner Pharmacy Recalls Succinylcholine Syringes Due to Sterility Concerns

    Banner Pharmacy Services is recalling 2,792 syringes of Succinylcholine 200 mg/10 mL because the product lacks assurance of sterility.

    Product
    Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0021-2018·2017-11-01

    Banner Pharmacy Recalls Midazolam Cassettes Due to Sterility Concerns

    Banner Pharmacy Services is recalling 966 cassettes of Midazolam HCL 100 mg due to a lack of assurance of sterility. The affected products were distributed nationwide.

    Product
    Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0016-2018·2017-11-01

    Banner Pharmacy Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Banner Pharmacy Services is recalling ephedrine sulfate syringes because the company cannot ensure the product is sterile.

    Product
    ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0019-2018·2017-11-01

    FDA Recalls Hydromorphone Syringes Due to Sterility Concerns

    Banner Pharmacy Services is recalling specific lots of Hydromorphone HCl syringes because the FDA determined there is a lack of assurance of sterility.

    Product
    Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0022-2018·2017-11-01

    Banner Pharmacy Recalls Norepinephrine Bags Due to Sterility Concerns

    Banner Pharmacy Services is recalling 3,550 bags of Norepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501
    Category
    Drug
    Distribution
    Distributed nationwide