Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 206 of 548
FDA Devices Moderate Aug 26, 2020
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone…
Argon Medical Devices, Inc
FDA Devices Moderate Aug 26, 2020
Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated…
Golden Technologies, Inc.
FDA Devices Moderate Aug 26, 2020
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (os…
NOBEL BIOCARE SERVICES AG
FDA Devices Moderate Aug 26, 2020
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion par…
CareFusion 303, Inc.
FDA Devices Moderate Aug 26, 2020
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming …
CareFusion 303, Inc.
FDA Devices Moderate Aug 26, 2020
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Smith & Nephew, Inc.
FDA Devices Moderate Aug 26, 2020
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areol…
Pharmaceutical Innovations, Inc.
FDA Devices Moderate Aug 26, 2020
Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and different…
Chembio Diagnostics, Inc
FDA Devices Moderate Aug 26, 2020
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring Syst…
Philips North America, LLC
FDA Devices Moderate Aug 26, 2020
Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) an…
Chembio Diagnostics, Inc
FDA Devices Moderate Aug 26, 2020
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-…
Synthes (USA) Products LLC
FDA Devices Moderate Aug 26, 2020
PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1
Whirlpool Corporation
FDA Food Critical Aug 19, 2020
Iron Drops (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL amber glass bottle packaged in an individual product carton that includes a 1 mL …
Wellements LLC
FDA Food Critical Aug 19, 2020
Iron Drops Sampler (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL, (2 mL fill) amber glass bottle packaged in an individual product carton …
Wellements LLC
FDA Devices Moderate Aug 19, 2020
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with oste…
Smith & Nephew, Inc.
FDA Devices Moderate Aug 19, 2020
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use d…
Luminex Corporation
FDA Devices Moderate Aug 19, 2020
Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstr…
Flower Orthopedics Corporation
FDA Devices Moderate Aug 19, 2020
Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstr…
Flower Orthopedics Corporation
FDA Devices Moderate Aug 19, 2020
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation faste…
Anjon Holdings
FDA Devices Moderate Aug 19, 2020
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Brainlab AG
FDA Devices Moderate Aug 19, 2020
STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
HF Acquisition Co., LLC
FDA Devices Moderate Aug 19, 2020
STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
HF Acquisition Co., LLC
FDA Devices Moderate Aug 19, 2020
Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniation, and reo…
Intrinsic Therapeutics, Inc.
FDA Devices Moderate Aug 19, 2020
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Brainlab AG
FDA Devices Moderate Aug 19, 2020
Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both …
Wright Medical Technology, Inc.
FDA Devices Moderate Aug 19, 2020
STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
HF Acquisition Co., LLC
FDA Devices Moderate Aug 19, 2020
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use d…
Luminex Corporation
FDA Devices Moderate Aug 19, 2020
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be u…
NeuroLogica Corporation
FDA Devices Moderate Aug 19, 2020
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in…
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Aug 19, 2020
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI:…
Bioseal Corporation
FDA Devices Moderate Aug 19, 2020
Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been…
Arrow International Inc
FDA Devices Moderate Aug 19, 2020
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536…
Philips North America, LLC
FDA Devices Moderate Aug 19, 2020
Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstr…
Flower Orthopedics Corporation
FDA Devices Moderate Aug 19, 2020
STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and m…
HF Acquisition Co. LLC
FDA Devices Low Aug 19, 2020
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individu…
Linet Americas
FDA Devices Moderate Aug 19, 2020
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro dia…
Ortho Clinical Diagnostics
FDA Devices Moderate Aug 12, 2020
Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavit…
TELEFLEX MEDICAL INC
FDA Devices Moderate Aug 12, 2020
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use de…
Boss Instruments, Ltd.
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
FDA Devices Moderate Aug 12, 2020
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connect…
Normand-Info S.A.S.U.
FDA Devices Critical Aug 12, 2020
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Critical Aug 12, 2020
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
FDA Devices Critical Aug 12, 2020
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Critical Aug 12, 2020
Alaris Pump Module Model 8100
CareFusion 303, Inc.
FDA Devices Critical Aug 12, 2020
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Moderate Aug 12, 2020
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Aug 12, 2020
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomi…
Siemens Medical Solutions USA, Inc