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
Vygon U.s.a.
PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in e...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pac...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external p...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibr...
Cardiac Devices·18,720 affected·Feb 23, 2018
RecallFDA
Akorn, Inc.
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC...
Ophthalmic Drugs·31,812 affected·Feb 21, 2018
High RiskFDA
Transonic Systems Inc
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extrac...
Cardiac Devices·6,044 affected·Feb 15, 2018
CriticalFDA
Pfizer Inc.
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lak...
Injectable Drugs·29 affected·Feb 7, 2018
CriticalFDA
Pfizer Inc.
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Paren...
Injectable Drugs·53,600 affected·Feb 7, 2018
High RiskFDA
Zimmer Biomet, Inc.
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 2...
Medical Devices·0 affected·Feb 6, 2018
High RiskFDA
Zimmer Biomet, Inc.
AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08...
Medical Devices·0 affected·Feb 6, 2018
High RiskFDA
Pharmedium Services, Llc
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Drugs·21 affected·Feb 5, 2018
High RiskFDA
Pharmedium Services, Llc
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Injectable Drugs·500 affected·Feb 5, 2018
High RiskFDA
Pharmedium Services, Llc
15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
Injectable Drugs·24 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, It...
Surgical Devices·11,500 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, St...
Surgical Devices·7,600 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The...
Surgical Devices·100 affected·Feb 5, 2018
High RiskFDA
Shippert Medical Technologies
Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medica...
Medical Devices·6,553 affected·Feb 2, 2018
High RiskFDA
Cook Inc.
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
Medical Devices·629 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606;...
Medical Devices·12,556 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Medical Devices·470 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
Medical Devices·751 affected·Jan 31, 2018
High RiskFDA
Orthofix Srl
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX ...
Surgical Devices·408 affected·Jan 30, 2018
RecallFDA
Jcb Laboratories Llc
Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Onl...
Injectable Drugs·6,510 affected·Jan 24, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Medical Implants·55 affected·Jan 23, 2018
High RiskFDA
3m Company - Health Care Business
3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is...
Medical Devices·36 affected·Jan 23, 2018
High RiskFDA
Sun Pharmaceutical Industries, Inc.
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries...
Injectable Drugs·393 affected·Jan 16, 2018
High RiskFDA
Medtronic Perfusion Systems
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Fi...
Medical Devices·8,644 affected·Jan 16, 2018
CriticalFDA
The Compounding Pharmacy Of America
HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of...
Injectable Drugs·5 affected·Jan 12, 2018
High RiskFDA
Howmedica Osteonics Corp.
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthr...
Medical Implants·6 affected·Jan 12, 2018
High RiskFDA
Medline Industries, Inc.
BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
Medical Devices·6 affected·Jan 12, 2018
High RiskFDA
Ellex Iscience, Inc.
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScien...
Surgical Devices·90 affected·Jan 11, 2018
CriticalFDA
Advanced Pharma Inc.
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Hou...
Drugs·25 affected·Jan 5, 2018
CriticalFDA
Aurobindo Pharma Ltd.
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Phar...
Injectable Drugs·53,040 affected·Jan 2, 2018
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The R...
Cardiac Devices·170 affected·Jan 2, 2018
High RiskFDA
Epimed International
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Medical Devices·140 affected·Dec 28, 2017
High RiskFDA
Pharmedium Services, Llc
Glycopyrrolate in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Labetalol HCl in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
Drugs·297 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Succinylcholine Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017