December 4, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva TX Interventional Coil 3.0T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration
Hazard: May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Hazard: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ9
Hazard: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ90
Hazard: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
December 4, 2024Medical DevicesFDA
Boston Scientific Corporation recalls AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Hazard: Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
December 4, 2024Medical DevicesFDA
Boston Scientific Corporation recalls AMS Artificial Urinary Sphincter Control Pump
Hazard: Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
December 4, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Hazard: Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
December 4, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Hazard: Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
December 4, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Hazard: Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
December 4, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x
Hazard: Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
December 4, 2024Medical DevicesFDA
Zyno Medical LLC recalls Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is i
Hazard: For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
December 4, 2024Medical DevicesFDA
Kreatech Biotechnology Bv recalls Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V
Hazard: The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.
December 4, 2024Medical DevicesFDA
MicroSurgical Technology Inc recalls Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps a
Hazard: Due to pin coming off of handles.
December 4, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVER
Hazard: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
December 4, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Hazard: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
December 4, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Hazard: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
December 4, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery MR750w 3.0T, whole body magnetic resonance scanner
Hazard: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
December 4, 2024Medical DevicesFDA
Smith & Nephew Medical, Ltd. recalls RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may
Hazard: Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL
Hazard: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A
Hazard: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) T
Hazard: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COM
Hazard: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF
Hazard: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STER
Hazard: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND
Hazard: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
Hazard: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
December 4, 2024Medical DevicesFDA
KCI USA, INC. recalls V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an
Hazard: Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
December 4, 2024Medical DevicesFDA
Defibtech, LLC recalls Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline E
Hazard: Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
December 4, 2024Medical DevicesFDA
Defibtech, LLC recalls Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG,
Hazard: Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient