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
Orthofix, Inc
T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
Medical Devices·36 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Lar...
Medical Devices·0 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12M...
Medical Devices·1,206 affected·Apr 6, 2018
High RiskFDA
Smiths Medical Asd Inc.
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Medical Devices·16 affected·Apr 2, 2018
High RiskFDA
Ge Medical Systems, Llc
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (pr...
Cardiac Devices·54 affected·Mar 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Medical Devices·108 affected·Mar 28, 2018
High RiskFDA
Auromedics Pharma Llc
Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufac...
Injectable Drugs·308,112 affected·Mar 27, 2018
High RiskFDA
Auromedics Pharma Llc
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedi...
Injectable Drugs·67,300 affected·Mar 27, 2018
High RiskFDA
Auromedics Pharma Llc
Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics ...
Injectable Drugs·261,250 affected·Mar 27, 2018
High RiskFDA
Auromedics Pharma Llc
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufact...
Injectable Drugs·46,824 affected·Mar 27, 2018
High RiskFDA
Auromedics Pharma Llc
Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufac...
Injectable Drugs·308,472 affected·Mar 27, 2018
High RiskFDA
Auromedics Pharma Llc
Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pa...
Injectable Drugs·395,150 affected·Mar 27, 2018
High RiskFDA
Auromedics Pharma Llc
Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedic...
Injectable Drugs·188,941 affected·Mar 27, 2018
High RiskFDA
Trilliant Surgical Ltd.
Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
Medical Devices·90 affected·Mar 27, 2018
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Tornier, Inc
AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabil...
Medical Devices·3,327 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Biomerieux Sa
The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test ...
Medical Devices·5 affected·Mar 23, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 8911...
Drugs·7 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) ...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 ...
Drugs·1 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Ph...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 79...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) ...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas,...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101,...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharma...
Injectable Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las V...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (70...
Drugs·7 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone 50 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) ...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Estradiol 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las V...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone Propionate 100mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 ...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 79...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las ...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702)...
Drugs·0 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. East...
Injectable Drugs·15 affected·Mar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702)...
Drugs·2 affected·Mar 22, 2018