Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 211 of 548
FDA Devices Moderate Jul 8, 2020
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Baxter Healthcare Corporation
FDA Devices Moderate Jul 8, 2020
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laborato…
Siemens Healthcare Diagnostics Inc.
FDA Devices Moderate Jul 8, 2020
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Elekta Instrument AB
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020
Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Ortho Organizers, Inc.
FDA Devices Moderate Jul 8, 2020
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Leng…
Westmed, Inc.
FDA Devices Moderate Jul 8, 2020
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Ortho Clinical Diagnostics
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Smiths Medical ASD Inc.
FDA Devices Critical Jul 8, 2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
Arrow International Inc
FDA Devices Moderate Jul 8, 2020
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Ortho Clinical Diagnostics
FDA Devices Moderate Jul 8, 2020
Elekta Unity, Image-Guided Radiation Therapy System
Elekta, Inc.
FDA Devices Moderate Jul 8, 2020
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
LivaNova Deutschland GmbH
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
LivaNova USA Inc.
FDA Devices Critical Jul 8, 2020
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
Arrow International Inc
FDA Drug Low Jul 1, 2020
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08…
QuVa Pharma, Inc.
FDA Devices Moderate Jul 1, 2020
Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and …
PROVIDENCE MEDICAL TECHNOLOGIES
FDA Devices Moderate Jul 1, 2020
HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental d…
Coltene Whaledent Inc
FDA Devices Moderate Jul 1, 2020
ADVIA Chemistry Calibrator
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 1, 2020
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam…
Coltene Whaledent Inc
FDA Devices Moderate Jul 1, 2020
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 1, 2020
Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.…
Hocoma AG
FDA Devices Moderate Jul 1, 2020
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042…
GE Healthcare, LLC
FDA Devices Low Jul 1, 2020
Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vi…
Utak Laboratories Inc
FDA Devices Moderate Jul 1, 2020
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jul 1, 2020
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Tosoh Bioscience Inc
FDA Devices Moderate Jul 1, 2020
Oscar 2, Model 250 System
Suntech Medical, Inc.
FDA Devices Moderate Jul 1, 2020
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is…
Merge Healthcare, Inc.
FDA Devices Moderate Jul 1, 2020
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Zest Anchors LLC
FDA Devices Moderate Jul 1, 2020
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental da…
Coltene Whaledent Inc
FDA Devices Moderate Jul 1, 2020
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Jul 1, 2020
MEVION S250i, MEVION S250; Proton Radiation Treatment System
Mevion Medical Systems, Inc.
FDA Devices Moderate Jul 1, 2020
BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automati…
Argon Medical Devices, Inc
FDA Devices Moderate Jul 1, 2020
Atellica CH Chemistry Calibrator
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jun 24, 2020
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, s…
Angiodynamics, Inc.
FDA Devices Moderate Jun 24, 2020
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the te…
Stryker GmbH
FDA Devices Moderate Jun 24, 2020
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E246…
Defibtech, LLC
FDA Devices Moderate Jun 24, 2020
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
GE Healthcare, LLC
FDA Devices Moderate Jun 24, 2020
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quan…
Ortho-Clinical Diagnostics
FDA Devices Moderate Jun 24, 2020
BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous…
Angiodynamics, Inc.
FDA Devices Moderate Jun 24, 2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intende…
Stryker GmbH
FDA Devices Moderate Jun 24, 2020
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A10…
Defibtech, LLC
FDA Devices Moderate Jun 24, 2020
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use …
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Jun 24, 2020
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Biomet
FDA Devices Moderate Jun 24, 2020
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intende…
Stryker GmbH
FDA Devices Moderate Jun 24, 2020
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-us…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Jun 24, 2020
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Diasol, Inc