FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 47 of 520
Moderate Dec 4, 2024
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-steri…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 4, 2024
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog N…
MicroSurgical Technology Inc
Moderate Dec 4, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Smiths Medical ASD, Inc.
Moderate Dec 4, 2024
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 4, 2024
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, n…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Moderate Dec 4, 2024
dS Breast 7ch 3.0T
Philips North America Llc
Moderate Dec 4, 2024
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Dec 4, 2024
GE Proteus XR/A radiographic system
GE Healthcare (China) Co., Ltd.
Low Dec 4, 2024
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenou…
Zyno Medical LLC
Moderate Dec 4, 2024
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via re…
Smith & Nephew Medical, Ltd.
Moderate Dec 4, 2024
ST SENSE Breast Dx Coil
Philips North America Llc
Moderate Dec 4, 2024
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management…
KCI USA, INC.
Low Dec 4, 2024
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart devi…
Abbott Medical
Moderate Dec 4, 2024
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 4, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Smiths Medical ASD, Inc.
Moderate Dec 4, 2024
Discovery MR750w 3.0T, whole body magnetic resonance scanner
GE Medical Systems, LLC
Moderate Dec 4, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Smiths Medical ASD, Inc.
Moderate Dec 4, 2024
SENSE Breast Coil
Philips North America Llc
Moderate Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Moderate Dec 4, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Micro-X Ltd.
Moderate Dec 4, 2024
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 4, 2024
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Dec 4, 2024
MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) E…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Moderate Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Moderate Dec 4, 2024
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victi…
Defibtech, LLC
Moderate Dec 4, 2024
Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of s…
Defibtech, LLC
Moderate Nov 27, 2024
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Ma…
Enchroma Inc
Moderate Nov 27, 2024
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Maquet Cardiovascular, LLC
Moderate Nov 27, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Hobbs Medical, Inc.
Critical Nov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Moderate Nov 27, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Caire, Inc.
Moderate Nov 27, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Hobbs Medical, Inc.
Critical Nov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Moderate Nov 27, 2024
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriform…
NuVasive Specialized Orthopedics, Inc.
Moderate Nov 27, 2024
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Abbott Medical
Moderate Nov 27, 2024
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Abbott Medical
Moderate Nov 27, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Hobbs Medical, Inc.
Moderate Nov 27, 2024
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusi…
Zyno Medical LLC
Moderate Nov 27, 2024
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Roche Diagnostics Operations, Inc.
Moderate Nov 27, 2024
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Abbott Medical
Critical Nov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Moderate Nov 27, 2024
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Abbott Medical
Moderate Nov 27, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Hobbs Medical, Inc.
Moderate Nov 27, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
Hobbs Medical, Inc.
Moderate Nov 27, 2024
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Maquet Cardiovascular, LLC
Moderate Nov 27, 2024
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Smiths Medical ASD, Inc.
Moderate Nov 27, 2024
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Versi…
Olympus Corporation of the Americas
Moderate Nov 27, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Hobbs Medical, Inc.