Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 4,551–4,600 of 7,959
- Class II
Medical Device Recall · October 31, 2024
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 30, 2024
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
- Class II
Medical Device Recall · October 29, 2024
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
- Class II
Medical Device Recall · October 29, 2024
SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: NoDue to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
- Class II
Medical Device Recall · October 29, 2024
SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: NoDue to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
- Class II
Medical Device Recall · October 29, 2024
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis componentFemoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
- Class III
Medical Device Recall · October 28, 2024
Remote Diagnostic Technologies Ltd.
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker modeDue to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
- Class II
Medical Device Recall · October 28, 2024
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Class II
Medical Device Recall · October 28, 2024
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging SystemGradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Class II
Medical Device Recall · October 28, 2024
AMS Artificial Urinary Sphincter Control PumpPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
- Class II
Medical Device Recall · October 28, 2024
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2OPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
- Class II
Medical Device Recall · October 28, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JPSmiths 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.
- Class II
Medical Device Recall · October 28, 2024
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
- Class II
Medical Device Recall · October 28, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JPSmiths 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.
- Class II
Medical Device Recall · October 28, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76Smiths 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.
- Class II
Medical Device Recall · October 28, 2024
Discovery MR750w 3.0T, whole body magnetic resonance scannerGradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Class II
Medical Device Recall · October 28, 2024
SIGNA Architect, Nuclear Magnetic Resonance Imaging SystemGradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Class II
Medical Device Recall · October 25, 2024
Galaxy System (GAL-001)Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.
- Class II
Medical Device Recall · October 25, 2024
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.
- Class II
Medical Device Recall · October 25, 2024
MEDLINE INDUSTRIES, LP - Northfield
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
- Class II
Medical Device Recall · October 24, 2024
GE Healthcare (China) Co., Ltd.
GE Proteus XR/A radiographic systemSteel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Lab Kit, SKU DYLAB1018; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
UA KIT, SKU DYKM1690A; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV19During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINE KIT, SKU DYKM1845; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Clean Catch Kit, SKU DYKM1833A; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class I
Medical Device Recall · October 22, 2024
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump ListICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
- Class II
Medical Device Recall · October 22, 2024
Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Class II
Medical Device Recall · October 22, 2024
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Class II
Medical Device Recall · October 22, 2024
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Class II
Medical Device Recall · October 22, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
- Class II
Medical Device Recall · October 21, 2024
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
- Class II
Medical Device Recall · October 21, 2024
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PCDue to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
- Class II
Medical Device Recall · October 21, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
- Class II
Medical Device Recall · October 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.