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
Tmc Acquisition Llc Dba Tailor Made Compounding
Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding
Drugs·4 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
Drugs·1,562 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
Drugs·485 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding
Supplements·75 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding
Drugs·232 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding
Drugs·273 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor Made Compounding
Drugs·41 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding
Supplements·6 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding
Drugs·106 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Drugs·63 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding
Drugs·26 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
Drugs·39 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Drugs·2,870 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding
Drugs·58 affected·Mar 7, 2022
High RiskFDA
Tmc Acquisition Llc Dba Tailor Made Compounding
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
Drugs·464 affected·Mar 7, 2022
High RiskFDA
Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intend...
Medical Devices·6,946 affected·Mar 3, 2022
High RiskFDA
Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intend...
Medical Devices·1,486 affected·Mar 3, 2022
High RiskFDA
B. Braun Medical, Inc.
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Injectable Drugs·33,742 affected·Feb 25, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Surgical Devices·348 affected·Feb 25, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Surgicare Neuro Pack - Neurological Kit
Medical Devices·176 affected·Feb 25, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Anterior Hip Pack - Surgical Kit
Surgical Devices·100 affected·Feb 25, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Total Knee Pack - Surgical Kit
Surgical Devices·76 affected·Feb 25, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Sterile Epidural Tray Catalog Number: 6259R2
Medical Devices·50 affected·Feb 22, 2022
High RiskFDA
Sa3, Llc
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Medical Devices·156 affected·Feb 21, 2022
High RiskFDA
Biomet, Inc.
BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, whic...
Medical Devices·12 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #1100182...
Medical Devices·702 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X1...
Medical Devices·2,594 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [It...
Medical Devices·38 affected·Feb 14, 2022
High RiskFDA
Brius Technologies Inc.
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Devi...
Medical Devices·4 affected·Feb 7, 2022
CriticalFDA
Coopersurgical, Inc
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek poly...
Drugs·48,645 affected·Feb 4, 2022
High RiskFDA
Philips North America Llc
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STER...
Cardiac Devices·331,712 affected·Feb 4, 2022
High RiskFDA
Integrity Implants Inc.
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal inter...
Medical Devices·1,702 affected·Jan 27, 2022
High RiskFDA
Integrity Implants Inc.
LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlamin...
Medical Devices·1,369 affected·Jan 27, 2022
CriticalFDA
Auromedics Pharma Llc
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: Au...
Injectable Drugs·35,520 affected·Jan 26, 2022
High RiskFDA
Cardinal Healthcare
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 ...
Drugs·2 affected·Jan 26, 2022
High RiskFDA
Surgical Innovations Ltd
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Medical Devices·1 affected·Jan 20, 2022
High RiskFDA
Surgical Innovations Ltd
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparosc...
Medical Devices·19 affected·Jan 20, 2022
High RiskFDA
Merete Medical Gmbh
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Medical Devices·26 affected·Jan 18, 2022
High RiskFDA
Lacrimedics Inc
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Medical Devices·4,780 affected·Jan 17, 2022
High RiskFDA
Aurobindo Pharma Usa Inc.
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, ...
Ophthalmic Drugs·115,776 affected·Jan 14, 2022
High RiskFDA
Exela Pharma Sciences Llc
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Scien...
Injectable Drugs·18,960 affected·Jan 11, 2022
High RiskFDA
Balt Usa, Llc
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainle...
Medical Implants·51 affected·Jan 4, 2022
High RiskFDA
Teva Pharmaceuticals Usa
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northsta...
Injectable Drugs·7,400 affected·Dec 31, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva ...
Injectable Drugs·11,450 affected·Dec 31, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Medical Devices·254 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 44-20-260-035 Material Number: M00573040
Medical Devices·3,578 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Medical Devices·112 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 44-30MM/260CM Material Number: M00584050
Medical Devices·12,067 affected·Dec 22, 2021