Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 216 of 548
FDA Devices Moderate Jun 3, 2020
Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription u…
Boston Scientific Neuromodulation Corporation
FDA Devices Moderate Jun 3, 2020
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technolog…
Radiometer Medical ApS
FDA Devices Moderate Jun 3, 2020
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricul…
Philips North America, LLC
FDA Devices Moderate Jun 3, 2020
GENTLEWAVE REF: FG-002-0001
Sonendo Inc
FDA Devices Moderate Jun 3, 2020
The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid…
Boston Scientific Neuromodulation Corporation
FDA Devices Moderate May 27, 2020
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained …
Philips North America, LLC
FDA Devices Moderate May 27, 2020
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63…
Baylis Medical Company Inc.
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative…
Cardinal Health Inc.
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during ca…
Applied Medical Resources Corp
FDA Devices Moderate May 27, 2020
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for t…
Skeletal Kinetics, Llc
FDA Devices Low May 27, 2020
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SL…
Pega Medical Inc.
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is in…
Medline Industries Inc
FDA Devices Moderate May 27, 2020
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is …
Medline Industries Inc
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
Prismaflex Control Unit
Baxter Healthcare Corporation
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reage…
Becton Dickinson & Co.
FDA Devices Moderate May 27, 2020
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
Becton Dickinson & Company
FDA Devices Moderate May 27, 2020
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a…
The Binding Site Group, Ltd.
FDA Devices Moderate May 27, 2020
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435
Becton Dickinson & Company
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545…
Baylis Medical Company Inc.
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during ca…
Applied Medical Resources Corp
FDA Devices Moderate May 27, 2020
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus vi…
Capso Vision, Inc.
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 10888857108684, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Clinical Innovations, LLC
FDA Devices Moderate May 27, 2020
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: …
Philips North America, LLC
FDA Devices Moderate May 27, 2020
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A
Becton Dickinson & Company
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276
Becton Dickinson & Company
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
Becton Dickinson & Company
FDA Devices Moderate May 27, 2020
STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during ca…
Applied Medical Resources Corp
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagen…
Becton Dickinson & Co.
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 10888857108905, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Becton Dickinson & Company
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Siz…
K2M, Inc
FDA Devices Low May 27, 2020
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical trea…
Immersivetouch Inc