PlainRecalls

Medical Devices Recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

27,372 recalls · Page 186 of 548

FDA Devices Moderate Mar 17, 2021

ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respir…

Draeger Medical, Inc.

FDA Devices Moderate Mar 17, 2021

Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no abi…

Getinge Group Logistics America, LLC

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

System INFX-8000C

Canon Medical System, USA, INC.

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Critical Mar 17, 2021

Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).

Medtronic Vascular, Inc.

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375

Medtronic Vascular

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage: intended for anterior cervical fixation …

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

System INFX-8000F

Canon Medical System, USA, INC.

FDA Devices Moderate Mar 17, 2021

Thread-like wire marker

Somatex Medical Technologies GMBH

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respi…

Draeger Medical, Inc.

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40

Medtronic Vascular

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Thermo Fisher Scientific

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Low Mar 17, 2021

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

OraSure Technologies, Inc.

FDA Devices Moderate Mar 10, 2021

TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.

Johnson & Johnson Surgical Vision Inc

FDA Devices Moderate Mar 10, 2021

Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move…

G & H Wire Company

FDA Devices Moderate Mar 10, 2021

ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic…

Bovie Medical Corporation

FDA Devices Moderate Mar 10, 2021

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561…

Boston Scientific Corporation

FDA Devices Moderate Mar 10, 2021

Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynami…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 10, 2021

Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation…

ReNovo, Inc.

FDA Devices Moderate Mar 10, 2021

HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

Hamilton Co

FDA Devices Moderate Mar 10, 2021

Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscop…

Bovie Medical Corporation

FDA Devices Moderate Mar 10, 2021

Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M0056…

Boston Scientific Corporation

FDA Devices Moderate Mar 10, 2021

Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: int…

BioFire Diagnostics, LLC

FDA Devices Moderate Mar 10, 2021

The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955…

Baxter Healthcare Corporation

FDA Devices Moderate Mar 10, 2021

BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.

BioFire Diagnostics, LLC

FDA Devices Moderate Mar 10, 2021

Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained…

Shanghai United Imaging Healthcare Co., Ltd.

FDA Devices Moderate Mar 10, 2021

Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; …

Boston Scientific Corporation

FDA Devices Moderate Mar 3, 2021

PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with var…

Respironics California, LLC

FDA Devices Moderate Mar 3, 2021

Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventric…

Natus Manufacturing Limited