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
Krs Global Biotechnology, Inc
Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147
Supplements·470 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Via...
Drugs·91 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce ...
Drugs·402 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL ...
Injectable Drugs·508 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce...
Injectable Drugs·0 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5...
Topical Drugs·242 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd...
Drugs·246 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 79...
Drugs·11,733 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, B...
Drugs·6,620 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use...
Injectable Drugs·60 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biote...
Injectable Drugs·878 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Us...
Injectable Drugs·708 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL...
Drugs·10,014 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Globa...
Drugs·12,445 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Comme...
Drugs·2,565 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Comme...
Injectable Drugs·1,464 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, B...
Injectable Drugs·1,189 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5...
Topical Drugs·1,815 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Bo...
Drugs·2,219 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Glob...
Injectable Drugs·3,820 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerc...
Injectable Drugs·2,760 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Comme...
Drugs·4,450 affected·Sep 12, 2019
High RiskFDA
Codan Us Corporation
CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on...
Medical Devices·34,776 affected·Sep 12, 2019
High RiskFDA
Stryker Corporation
Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 Th...
Surgical Devices·0 affected·Sep 12, 2019
CriticalFDA
Medtech Sas
Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film...
Medical Devices·93 affected·Sep 10, 2019
High RiskFDA
Pfizer Inc.
Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-...
Injectable Drugs·185,700 affected·Sep 6, 2019
High RiskFDA
Pacifico National, Inc. Dba Amex Pharmacy
Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabet...
Injectable Drugs·0 affected·Aug 30, 2019
High RiskFDA
Pacifico National, Inc. Dba Amex Pharmacy
Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth...
Injectable Drugs·0 affected·Aug 30, 2019
High RiskFDA
Pajunk Gmbh
SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22...
Diagnostic Devices·40,475 affected·Aug 30, 2019
High RiskFDA
Atlas Pharmaceuticals, Llc
Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy...
Injectable Drugs·1,646 affected·Aug 28, 2019
High RiskFDA
Zimmer Biomet, Inc.
COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 ...
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 1...
Medical Devices·214,741 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to fac...
Medical Implants·1,729 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-10...
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA...
Medical Devices·178,886 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
Comprehensive RS Cleat CAP, Item No. 110300
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom d...
Medical Devices·217,240 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP...
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Sca Pharmaceuticals, Llc
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuti...
Injectable Drugs·922 affected·Aug 16, 2019
High RiskFDA
Irrimax Corporation
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Medical Devices·1,031 affected·Aug 16, 2019
High RiskFDA
Bioseal Corporation
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XX...
Medical Devices·900 affected·Aug 15, 2019
High RiskFDA
Livanova Usa Inc
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual f...
Medical Devices·6 affected·Aug 13, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX
Drugs·2 affected·Aug 12, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.
Drugs·1 affected·Aug 12, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx
Injectable Drugs·0 affected·Aug 12, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx
Drugs·3 affected·Aug 12, 2019