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
Hospira Inc.
QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 040...
Injectable Drugs·139,200 affected·Feb 26, 2013
High RiskFDA
Hospira Inc.
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0...
Injectable Drugs·266,900 affected·Feb 26, 2013
High RiskFDA
Spinal Solutions, Llc
45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consi...
Surgical Devices·24 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consign...
Surgical Devices·106 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or ...
Surgical Devices·16 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 ...
Surgical Devices·35 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onse...
Medical Implants·57 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x...
Surgical Devices·56 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,...
Medical Implants·459 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous co...
Medical Implants·30 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller ...
Medical Implants·50 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium ...
Medical Devices·26 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm C...
Medical Implants·5 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large ...
Surgical Devices·24 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consign...
Surgical Devices·63 affected·Feb 20, 2013
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake...
Injectable Drugs·624,240 affected·Feb 18, 2013
High RiskFDA
Hospira Inc.
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
Injectable Drugs·567,624 affected·Feb 15, 2013
Medium RiskFDA
Becton Dickinson & Company
BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Comp...
Medical Devices·236,400 affected·Feb 14, 2013
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Drugs·56,854 affected·Feb 12, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia The...
Medical Devices·30,000 affected·Feb 8, 2013
High RiskFDA
Myco Medical Supplies Inc
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
Surgical Devices·110,768 affected·Feb 7, 2013
High RiskFDA
Conmed Corporation
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED...
Medical Devices·97,450 affected·Jan 28, 2013
High RiskFDA
Bacterin International, Inc.
Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, B...
Surgical Devices·15 affected·Jan 28, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use...
Medical Implants·4 affected·Jan 24, 2013
High RiskFDA
Bard Peripheral Vascular Inc
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, ...
Medical Implants·315 affected·Jan 23, 2013
High RiskFDA
Bard Peripheral Vascular Inc
MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered ti...
Surgical Devices·17 affected·Jan 23, 2013
High RiskFDA
Bard Peripheral Vascular Inc
USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; ...
Surgical Devices·223 affected·Jan 23, 2013
RecallFDA
Actelion Pharmaceuticals U.s., Inc.
Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceutical...
Drugs·3 affected·Jan 16, 2013
High RiskFDA
Breg Inc
BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410...
Medical Devices·44,883 affected·Jan 14, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·5 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·64 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·56 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·10 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·50 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·202 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·273 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·522 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·5 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·202 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·46 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·19 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·25 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·141 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·32 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·867 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·46 affected·Jan 11, 2013
High RiskFDA
Hospira, Inc.
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
Injectable Drugs·63,900 affected·Jan 10, 2013
High RiskFDA
Extremity Medical Llc
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained i...
Surgical Devices·238 affected·Jan 10, 2013