Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 5,301–5,350 of 8,689
- 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
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
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
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 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
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
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 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 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
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
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
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
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 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 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 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 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 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 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 I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 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 I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 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.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class II
Medical Device Recall · October 21, 2024
Siemens Healthcare Diagnostics, Inc.
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.
- 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 18, 2024
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
- Class II
Medical Device Recall · October 18, 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 infusion of parenteral fluids, blood, and blood productsPotential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
- Class II
Medical Device Recall · October 18, 2024
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with SoftwareHeart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
- Class II
Medical Device Recall · October 17, 2024
Roche Diagnostics Operations, Inc.
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteineAbnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
- Class II
Medical Device Recall · October 17, 2024
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- Class II
Medical Device Recall · October 17, 2024
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- Class II
Medical Device Recall · October 17, 2024
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- Class II
Medical Device Recall · October 17, 2024
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- Class II
Medical Device Recall · October 17, 2024
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- Class I
Medical Device Recall · October 16, 2024
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class II
Medical Device Recall · October 16, 2024
Smaxel Fractional CO2 Laser, a Class IV medical laser system.The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
- Class II
Medical Device Recall · October 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876AThe connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
- Class II
Medical Device Recall · October 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter ConnectorThe connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
- Class II
Medical Device Recall · October 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORThe connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
- Class II
Medical Device Recall · October 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699AThe connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
- Class II
Medical Device Recall · October 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622AThe connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.