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
Assurance Infusion
BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
Drugs·7 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·2 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·2 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
Drugs·166 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Intuitive Surgical, Inc.
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery usin...
Medical Devices·1,757 affected·Dec 19, 2019
High RiskFDA
Vitreq Bv
VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Vitreq Bv
VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Vitreq Bv
(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Vitreq Bv
VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Vitreq Bv
VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Vitreq Bv
VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Arthrex, Inc.
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Medical Devices·47 affected·Dec 17, 2019
High RiskFDA
Vitreq Bv
VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Vitreq Bv
VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Vitreq Bv
(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Vitreq Bv
VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
Medical Devices·0 affected·Dec 17, 2019
High RiskFDA
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system t...
Medical Devices·25 affected·Dec 16, 2019
High RiskFDA
Microbiologics Inc
Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems t...
Diagnostic Devices·810 affected·Dec 16, 2019
High RiskFDA
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system t...
Medical Devices·25 affected·Dec 16, 2019
High RiskFDA
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system t...
Medical Devices·25 affected·Dec 16, 2019
High RiskFDA
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system t...
Medical Devices·25 affected·Dec 16, 2019
RecallFDA
Lupin Pharmaceuticals Inc.
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pitham...
Ophthalmic Drugs·2,130 affected·Dec 13, 2019
High RiskFDA
Coopersurgical, Inc.
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product...
Surgical Devices·460 affected·Dec 13, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESS...
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- ENT SNUF3 SNUFFER KIT Y
Medical Devices·146 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
Medical Devices·108 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION T...
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY
Medical Devices·60 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY C...
Medical Devices·448 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
Medical Devices·100 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- OR2020 BASIN SET
Medical Devices·188 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
Medical Devices·1,100 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Port Draw Kit KNV30 PORT DRAW KIT
Medical Devices·75 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- LC145 STERILE NICU LINE CHANGE KIT
Medical Devices·160 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF109...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPO...
Medical Devices·0 affected·Dec 11, 2019