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
Zevex Incorporated (dba Moog Medical Devices Group)
MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 2...
Medical Devices·569 affected·Feb 27, 2019
RecallFDA
Teleflex Medical
Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
Surgical Devices·39,456 affected·Feb 27, 2019
High RiskFDA
Zevex Incorporated (dba Moog Medical Devices Group)
MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-...
Medical Devices·756 affected·Feb 27, 2019
High RiskFDA
Luminex Molecular Diagnostics
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial ...
Medical Devices·965 affected·Feb 22, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corval...
Injectable Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Injectable Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Cor...
Injectable Drugs·2 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. ...
Injectable Drugs·2 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR ...
Injectable Drugs·5 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corva...
Injectable Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 C...
Injectable Drugs·9 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97...
Injectable Drugs·25 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, O...
Injectable Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
Ophthalmic Drugs·6 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corval...
Ophthalmic Drugs·12 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis...
Injectable Drugs·2 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR...
Injectable Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvall...
Ophthalmic Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, ...
Injectable Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #...
Injectable Drugs·3 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 ...
Injectable Drugs·13 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corval...
Injectable Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd...
Injectable Drugs·3 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle B...
Injectable Drugs·4 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharma...
Injectable Drugs·64 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis,...
Injectable Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Injectable Drugs·1 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corva...
Injectable Drugs·2 affected·Feb 21, 2019
High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis...
Injectable Drugs·3 affected·Feb 21, 2019
High RiskFDA
Leiter's Enterprises, Inc.
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) ...
Injectable Drugs·569 affected·Feb 19, 2019
High RiskFDA
Tedan Surgical Innovations Llc
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Scre...
Medical Devices·199 affected·Feb 18, 2019
High RiskFDA
Tedan Surgical Innovations Llc
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and ...
Medical Devices·57 affected·Feb 18, 2019
High RiskFDA
Covidien Llc
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Medical Devices·25 affected·Feb 15, 2019
High RiskFDA
Bioventus, Llc
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to ...
Medical Devices·10,793 affected·Feb 13, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, P...
Drugs·8,500 affected·Feb 8, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Av...
Drugs·250 affected·Feb 8, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th A...
Drugs·4,950 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
Medical Devices·563,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Needle, 23G x 1", Product Code NN2325R
Medical Devices·30,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 20G x 1", Product Code 100204
Medical Devices·729,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 22G x 1", Product Code 100211
Medical Devices·444,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
Medical Devices·638,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Needle, 18G x 1", Product Code NN1825R
Medical Devices·810,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Needle, 30G x 1/2", Product Code NN3013R
Medical Devices·81,000 affected·Feb 8, 2019
RecallFDA
Advanced Pharma Inc.
Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use b...
Injectable Drugs·672 affected·Feb 6, 2019
RecallFDA
Advanced Pharma Inc.
Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag...
Injectable Drugs·1,460 affected·Feb 6, 2019
RecallFDA
Advanced Pharma Inc.
Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use b...
Injectable Drugs·12 affected·Feb 6, 2019
High RiskFDA
Advanced Pharma Inc.
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, R...
Injectable Drugs·100 affected·Feb 6, 2019