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
Partell Specialty Pharmacy
Testosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 7...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (7...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 891...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone 55 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 891...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. East...
Drugs11 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101...
Drugs5 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Drugs3 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 8911...
Drugs4 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone 100 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 8911...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1000 mg)/ vial liquid injectable, 50 mL amber vial, Rx only, ...
Injectable Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (7...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. # 101, Las Vegas,...
Injectable Drugs4 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, La...
Drugs1 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Estradiol 25 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791...
Drugs0 affectedMar 22, 2018
High RiskFDA
Partell Specialty Pharmacy
Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791...
Drugs2 affectedMar 22, 2018
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Medical Devices0 affectedMar 20, 2018
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Medical Devices0 affectedMar 20, 2018
High RiskFDA
Zimmer Gmbh
Normed Charcot Osteotome Chisel (Various sizes)
Medical Devices0 affectedMar 15, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap s...
Medical Implants298 affectedMar 14, 2018
High RiskFDA
Livanova Usa
Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute...
Respiratory Devices70 affectedMar 13, 2018
High RiskFDA
Livanova Usa
Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute ...
Respiratory Devices42 affectedMar 13, 2018
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) ...
Medical Implants231 affectedMar 13, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
Medical Devices5 affectedMar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
Medical Devices5 affectedMar 7, 2018
High RiskFDA
Smith & Nephew, Inc.
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T ...
Medical Devices59 affectedMar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
Medical Implants2 affectedMar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
Medical Devices10 affectedMar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Medical Implants2 affectedMar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
Medical Implants2 affectedMar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
Medical Implants2 affectedMar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Vascular Solutions Venture Rx Catheter, 6F, resterilized.
Surgical Devices3 affectedMar 7, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic de...
Medical Devices81 affectedMar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifol...
Medical Devices122 affectedMar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogeni...
Medical Devices50 affectedMar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic ...
Medical Devices100 affectedMar 1, 2018
High RiskFDA
Vygon U.s.a.
PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices16,520 affectedFeb 28, 2018
High RiskFDA
Vygon U.s.a.
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices16,520 affectedFeb 28, 2018
High RiskFDA
Vygon U.s.a.
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices16,520 affectedFeb 28, 2018
High RiskFDA
Vygon U.s.a.
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices16,520 affectedFeb 28, 2018
High RiskFDA
Vygon U.s.a.
Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices16,520 affectedFeb 28, 2018