January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-247
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (trache
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 9
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wi
Hazard: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of proced
Hazard: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
January 22, 2025Medical DevicesFDA
DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Hazard: The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.
January 22, 2025Medical DevicesFDA
SIN SISTEMA DE IMPLANTE NACIONAL S.A recalls Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Hazard: Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.
January 22, 2025Medical DevicesFDA
IsoTis OrthoBiologics, Inc. recalls OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Hazard: Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
January 22, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile
Hazard: There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Num
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVAS
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Numb
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSME
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Num
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SC
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Numbe
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Hologic, Inc. recalls Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Hazard: Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
January 22, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Hazard: Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
January 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is design
Hazard: Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
January 22, 2025Medical DevicesFDA
ev3 Inc recalls Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) A
Hazard: There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
January 22, 2025Medical DevicesFDA
ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adh
Hazard: Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
January 22, 2025Medical DevicesFDA
QUIDEL ORTHO recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 834338
Hazard: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
January 22, 2025Medical DevicesFDA
QUIDEL ORTHO recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 834338
Hazard: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001
Hazard: 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.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5)
Hazard: 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.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography,
Hazard: 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.