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
Zimmer Biomet, Inc.
Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip ...
Medical Implants9,867 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip ...
Medical Implants9,867 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip ...
Medical Implants9,867 affectedFeb 28, 2017
High RiskFDA
Conmed Corporation
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) c...
Surgical Devices0 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip ...
Medical Implants9,867 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants9,867 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Por fullct fem st 18x200mm, Sterile,
Medical Devices9,867 affectedFeb 28, 2017
High RiskFDA
Conmed Corporation
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) c...
Surgical Devices0 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants9,867 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants9,867 affectedFeb 28, 2017
High RiskFDA
Conmed Corporation
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) c...
Surgical Devices0 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants9,867 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants0 affectedFeb 28, 2017
High RiskFDA
Devicor Medical Products Inc
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious u...
Medical Devices320 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants0 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail I...
Medical Implants9,867 affectedFeb 28, 2017
RecallUSDA
Wayne Farms Llc
Wayne Farms, LLC Recalls Ready-To-Eat Chicken Products Due To Potential Processing Deviation
Poultry0 affectedFeb 28, 2017
High RiskFDA
Carefusion 2200 Inc
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
Medical Devices790 affectedFeb 23, 2017
High RiskFDA
Carefusion 2200 Inc
Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
Medical Devices1,200 affectedFeb 23, 2017
High RiskFDA
Streck
Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 21...
Medical Devices128,692 affectedFeb 23, 2017
High RiskFDA
Carefusion 2200 Inc
JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
Medical Devices14,200 affectedFeb 23, 2017
High RiskFDA
Endo Pharmaceuticals, Inc.
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, ...
Injectable Drugs5,086 affectedFeb 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality component...
Medical Implants28,253 affectedFeb 17, 2017
High RiskFDA
Sato Pharmaceutical Inc.
Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. ...
Ophthalmic Drugs10,130 affectedFeb 16, 2017
High RiskFDA
Sato Pharmaceutical Inc.
DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5...
Drugs14,325 affectedFeb 16, 2017
High RiskFDA
Sato Pharmaceutical Inc.
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuti...
Ophthalmic Drugs4,790 affectedFeb 16, 2017
High RiskFDA
Datascope Corporation
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are...
Cardiac Devices21 affectedFeb 16, 2017
High RiskFDA
Crossroads Extremity Systems Llc
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Medical Devices20 affectedFeb 16, 2017
High RiskFDA
Synergy Rx
REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 10%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego...
Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, C...
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% CREAM,...
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
INTIMATE BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
HYDROQUINONE 28% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
ULTRA LITE CREAM (Hydroquinone 8%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
CLARIFYING CREAM (Retinoic acid 0.025%, Salicylic Acid 1%, Green tea powder, Ascorbic acid 2%), Rx only, Synergy RX, 4901 Morena Blvd # 5...
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
HYDROQUINONE CREAM in all strengths including 4%, 5%,6%, 7%, 8%, HYDROQUINONE 5%/KOJIC ACID 3% CREAM, Rx only, Synergy RX, 4901 Morena B...
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
GENTLE SUPREME BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG 11,000/B-12 UNITS SOLUTION, Rx only, Synergy RX, 4901 Moren...
Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
ROSACEA CREAM ( Metronidazole 1%, Niacinamide 4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, ENHANCED RETIN 0.025% and 0.05%, Rx only, Synergy RX, 4901 Mor...
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
UREA 40% Cream, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
SULFUR 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017
High RiskFDA
Synergy Rx
SULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs0 affectedFeb 10, 2017