Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,901–4,950 of 8,689
- Class II
Medical Device Recall · December 19, 2024
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,FORCE BIPOLAR,IS4000 REF 470405Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM, POTTS SCISSORS, IS4000 REF 470001Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
Jinan Bodor Cnc Machine Co Ltd
Bodor P and C series laser cutting machinesNon-compliant laser products
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
BD PCR Cartridges used with MAX System. Model Number: 437519Potential for signal drift in specific lots of BD PCR Cartridges.
- Class II
Medical Device Recall · December 19, 2024
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,MEGA SUTURECUT ND,IS4000 REF 471309Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CEScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,COBRA GRASPER,IS4000 REF 471190Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,RESANO FORCEPS,IS4000 ¿ REF 470181Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ;GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class I
Medical Device Recall · December 18, 2024
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class I
Medical Device Recall · December 18, 2024
Olympus Corporation of the Americas
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allowPotential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnosticControl indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
- Class II
Medical Device Recall · December 18, 2024
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-7035R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, EmissGE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- Class II
Medical Device Recall · December 16, 2024
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydPotential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- Class II
Medical Device Recall · December 16, 2024
Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermiaThere is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
- Class II
Medical Device Recall · December 16, 2024
Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermiaThere is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
- Class I
Medical Device Recall · December 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBERFluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
- Class II
Medical Device Recall · December 16, 2024
Olympus Corporation of the Americas
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.Potential for distal tip tearing of the Mechanical Lithotriptor V.
- Class II
Medical Device Recall · December 16, 2024
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management ofPotential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- Class II
Medical Device Recall · December 16, 2024
Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermiaThere is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
- Class I
Medical Device Recall · December 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLEFluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
- Class II
Medical Device Recall · December 16, 2024
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydPotential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- Class II
Medical Device Recall · December 15, 2024
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 dComplaints have been received regarding post-operative implant collapse.