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
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
Medical Devices·7 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
Medical Devices·3 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
Medical Devices·4 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
Medical Devices·8 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
Medical Devices·10 affected·Apr 26, 2021
High RiskFDA
Meta C.g.m. Spa
REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
Medical Devices·1,692 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
Medical Devices·5 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
Medical Devices·18 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
Medical Devices·8 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
Medical Devices·7 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
Medical Devices·7 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
Medical Devices·26 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
Medical Devices·1 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
Medical Devices·0 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
Medical Devices·7 affected·Apr 26, 2021
High RiskFDA
Meta C.g.m. Spa
REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
Medical Devices·27 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378
Medical Devices·6 affected·Apr 26, 2021
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the perip...
Surgical Devices·690 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
Medical Devices·1 affected·Apr 26, 2021
High RiskFDA
Adler Micromed, Inc.
Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. D...
Surgical Devices·1,858 affected·Apr 23, 2021
High RiskFDA
Coopersurgical, Inc.
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not m...
Medical Devices·6 affected·Apr 23, 2021
High RiskFDA
Innovative Tomography Product Gmbh
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 1...
Medical Devices·0 affected·Apr 21, 2021
High RiskFDA
Innovative Tomography Product Gmbh
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length ...
Medical Devices·0 affected·Apr 21, 2021
High RiskFDA
Vygon U.s.a.
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Medical Devices·8,320 affected·Apr 15, 2021
High RiskFDA
Boston Scientific Corporation
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and...
Medical Devices·4,549 affected·Apr 15, 2021
RecallFDA
Nomax Inc
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Ma...
Ophthalmic Drugs·78 affected·Apr 13, 2021
High RiskFDA
Edge Pharma, Llc
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMI...
Topical Drugs·5,850 affected·Apr 12, 2021
High RiskFDA
Spes Medica
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached...
Surgical Devices·34 affected·Apr 8, 2021
High RiskFDA
Spes Medica
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuo...
Surgical Devices·20 affected·Apr 8, 2021
High RiskFDA
Spes Medica
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Medical Devices·3 affected·Apr 8, 2021
High RiskFDA
Clinical Laserthermia Systems Ab
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device ...
Medical Devices·40 affected·Apr 1, 2021
High RiskFDA
Clinical Laserthermia Systems Ab
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the i...
Medical Devices·40 affected·Apr 1, 2021
High RiskFDA
Clinical Laserthermia Systems Ab
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the...
Medical Devices·90 affected·Apr 1, 2021
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two ...
Medical Devices·321 affected·Apr 1, 2021
High RiskFDA
Zavation
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·72 affected·Mar 25, 2021
High RiskFDA
Zavation
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
Medical Devices·31 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.
Medical Devices·11 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Medical Devices·516 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·7 affected·Mar 25, 2021
High RiskFDA
Zavation
10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
Medical Devices·58 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·122 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
Medical Devices·195 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021