Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 210 of 548
FDA Devices Moderate Jul 15, 2020
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
CooperSurgical, Inc.
FDA Devices Moderate Jul 15, 2020
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 15, 2020
PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the …
TeDan Surgical Innovations LLC
FDA Devices Moderate Jul 15, 2020
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
Prodimed Plastimed Division
FDA Devices Moderate Jul 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit E…
Kentec Medical, Inc
FDA Devices Critical Jul 15, 2020
GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables…
Verathon, Inc.
FDA Devices Moderate Jul 15, 2020
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
CTL Medical Corporation
FDA Devices Moderate Jul 15, 2020
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in t…
FHC, Inc.
FDA Devices Moderate Jul 15, 2020
CareLink SmartSync Device Manager, Model Number 24970A
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 15, 2020
Azure S DR MRI, Model Number W3DR01
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 15, 2020
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, …
Cardinal Health 200, LLC
FDA Devices Moderate Jul 15, 2020
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. Th…
Radiometer Medical ApS
FDA Devices Moderate Jul 15, 2020
Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 15, 2020
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for…
Capso Vision, Inc.
FDA Devices Moderate Jul 15, 2020
Azure S SR MRI, Model Number W3SR01
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit En…
Kentec Medical, Inc
FDA Devices Moderate Jul 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit En…
Kentec Medical, Inc
FDA Devices Moderate Jul 15, 2020
Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 15, 2020
Patient Connector, Model Number 24967
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 15, 2020
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usa…
Abbott
FDA Devices Moderate Jul 15, 2020
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediat…
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Jul 15, 2020
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures …
Dufner Instrumente GmbH
FDA Devices Moderate Jul 15, 2020
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical sp…
TeDan Surgical Innovations LLC
FDA Devices Moderate Jul 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit E…
Kentec Medical, Inc
FDA Devices Moderate Jul 15, 2020
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
Philips North America, LLC
FDA Devices Moderate Jul 15, 2020
Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 15, 2020
PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the…
TeDan Surgical Innovations LLC
FDA Devices Moderate Jul 15, 2020
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological da…
Vitalconnect Inc.
FDA Devices Moderate Jul 15, 2020
PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the …
TeDan Surgical Innovations LLC
FDA Devices Moderate Jul 15, 2020
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Smiths Medical ASD Inc.
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functi…
Mediana Co., Ltd.
FDA Devices Moderate Jul 8, 2020
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
LivaNova USA Inc.
FDA Devices Critical Jul 8, 2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Arrow International Inc
FDA Devices Critical Jul 8, 2020
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
Arrow International Inc
FDA Devices Critical Jul 8, 2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
Arrow International Inc
FDA Devices Moderate Jul 8, 2020
Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 …
Ortho Organizers, Inc.
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF …
Westmed, Inc.
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020
Respirator Crash Cart Kit
ROi CPS LLC
FDA Devices Moderate Jul 8, 2020
PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W8…
Ethicon, Inc.
FDA Devices Moderate Jul 8, 2020
(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 8, 2020
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Ortho Clinical Diagnostics
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
LivaNova USA Inc.
FDA Devices Critical Jul 8, 2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
Arrow International Inc
FDA Devices Moderate Jul 8, 2020
CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label i…
Codan US Corporation
FDA Devices Critical Jul 8, 2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
Arrow International Inc
FDA Devices Moderate Jul 8, 2020
Isolation Droplet Bundle Kit
ROi CPS LLC