Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Pharm D Solutions, Llc
Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
Injectable Drugs·7,150 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1342-05
Drugs·25 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10
Drugs·765 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02
Drugs·430 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10
Drugs·25 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12
Drugs·29 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
Injectable Drugs·130 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, H...
Injectable Drugs·896 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10
Injectable Drugs·630 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05
Drugs·40 affected·Sep 10, 2018
High RiskFDA
Howmedica Osteonics Corp.
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. ...
Surgical Devices·15 affected·Sep 10, 2018
High RiskFDA
Coopersurgical, Inc.
Colpo-Pneumo Occluder, Part CPO-6
Medical Devices·32,538 affected·Sep 4, 2018
High RiskFDA
Coopersurgical, Inc.
Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316...
Medical Devices·18,000 affected·Sep 4, 2018
High RiskFDA
Arrow International Inc
Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) cent...
Medical Devices·105 affected·Aug 30, 2018
RecallFDA
Pfizer Inc.
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, I...
Injectable Drugs·1,580 affected·Aug 28, 2018
High RiskFDA
Life Technologies, Corp.
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
Diagnostic Devices·1,329 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Diagnostic Devices·1,912 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
Diagnostic Devices·240 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
Diagnostic Devices·41 affected·Aug 24, 2018
High RiskFDA
Safe N Simple, Llc
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Medical Devices·125 affected·Aug 22, 2018
High RiskFDA
Auro Pharmacies, Inc.
Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy...
Injectable Drugs·114 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Hab...
Injectable Drugs·90 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compo...
Injectable Drugs·32 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra,...
Injectable Drugs·183 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, ...
Injectable Drugs·91 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra,...
Injectable Drugs·39 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Co...
Injectable Drugs·43 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Ha...
Injectable Drugs·74 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Co...
Injectable Drugs·11 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, ...
Injectable Drugs·40 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Ha...
Injectable Drugs·81 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, C...
Injectable Drugs·167 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for u...
Medical Devices·73 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for us...
Medical Devices·452 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO I...
Medical Devices·1,517 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for us...
Medical Devices·169 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Medical Devices·106 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated f...
Medical Devices·241 affected·Aug 21, 2018
High RiskFDA
Icu Medical, Inc.
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a sin...
Surgical Devices·2,361 affected·Aug 20, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
Surgical Devices·50 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
Medical Devices·48 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
Medical Devices·150 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664
Medical Devices·48 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
Medical Devices·24 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
Medical Devices·72 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
Medical Devices·100 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
Medical Devices·300 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
Medical Devices·4,500 affected·Aug 13, 2018