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
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
Injectable Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
CriticalFDA
Imperative Care Inc
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx O...
Surgical Devices·3,118 affected·Aug 13, 2021
High RiskFDA
Anhui Welcome Foreign Trade Co.,ltd.
Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)Int...
Ophthalmic Drugs·63,750 affected·Aug 12, 2021
High RiskFDA
Cypress Medical Products Llc
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Medical Devices·1 affected·Aug 11, 2021
High RiskFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Platt...
Injectable Drugs·3,378 affected·Aug 10, 2021
High RiskFDA
Convatec, Inc
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing...
Medical Devices·2,734,830 affected·Aug 9, 2021
High RiskFDA
Smiths Medical Asd Inc.
Bivona Aire-Cuf Endotracheal Tube
Medical Devices·7,136 affected·Aug 9, 2021
High RiskFDA
Xellia Pharmaceuticals Usa, Llc
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharma...
Injectable Drugs·9,161 affected·Aug 6, 2021
High RiskFDA
Xellia Pharmaceuticals Usa, Llc
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmac...
Injectable Drugs·9,161 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens)...
Surgical Devices·5 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), S...
Surgical Devices·333 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabil...
Surgical Devices·58 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabil...
Surgical Devices·3 affected·Aug 6, 2021
High RiskFDA
Johnson & Johnson Surgical Vision Inc
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery Sys...
Medical Implants·1 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens)...
Surgical Devices·98 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumen...
Surgical Devices·6,395 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous in...
Surgical Devices·1,253 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion cap...
Surgical Devices·2,833 affected·Aug 6, 2021
High RiskFDA
Medline Industries Inc
NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx on...
Medical Devices·816,420 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HE...
Surgical Devices·1,256 affected·Aug 6, 2021
High RiskFDA
Intuitive Surgical, Inc.
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Medical Devices·1,625 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens...
Surgical Devices·1,733 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capab...
Surgical Devices·5,524 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only,...
Surgical Devices·4,812 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumen...
Surgical Devices·11 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEP...
Surgical Devices·33,066 affected·Aug 6, 2021
High RiskFDA
M.d.l. S.r.l.
Soft Tissue Biopsy Needles
Medical Devices·20,129 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
Mammary Nodules Localization
Medical Devices·320 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
General Manual surgical instrument
Surgical Devices·4,120 affected·Aug 5, 2021
CriticalFDA
Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in f...
Medical Devices·267,217,860 affected·Aug 4, 2021
CriticalFDA
Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in ...
Medical Devices·267,217,860 affected·Aug 4, 2021
CriticalFDA
Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in...
Medical Devices·267,217,860 affected·Aug 4, 2021
High RiskFDA
Olympus Corporation Of The Americas
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420...
Medical Devices·711,157 affected·Aug 3, 2021
High RiskFDA
Akorn, Inc.
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, ...
Topical Drugs·142,188 affected·Aug 2, 2021
High RiskFDA
Baycare Integrated Service Center, Llc /dba Baycare Central Pharmacy
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkw...
Injectable Drugs·253 affected·Jul 30, 2021
High RiskFDA
Custopharm, Inc.
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92...
Injectable Drugs·19,384 affected·Jul 30, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
Injectable Drugs·12,698 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, C...
Injectable Drugs·1,351 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, N...
Injectable Drugs·434,229 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Do...
Injectable Drugs·193,845 affected·Jul 29, 2021