FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 42 of 520
Moderate Jan 22, 2025
8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA N…
Sklar Instruments
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Sklar Instruments
Moderate Jan 22, 2025
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, T…
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Jan 22, 2025
Change Healthcare Cardiology Hemo software
A L I Technologies Ltd
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUE…
Sklar Instruments
Moderate Jan 22, 2025
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL …
Cardinal Health 200, LLC
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSE…
Sklar Instruments
Moderate Jan 22, 2025
Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI S…
Cardinal Health 200, LLC
Critical Jan 22, 2025
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Trokamed GmbH
Moderate Jan 22, 2025
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
NOA Medical Industries Inc
Moderate Jan 22, 2025
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Critical Jan 22, 2025
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Boston Scientific Corporation
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
Sklar Instruments
Moderate Jan 22, 2025
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution component…
GE Medical Systems, LLC
Moderate Jan 22, 2025
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Accriva Diagnostics, Inc.
Moderate Jan 22, 2025
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW…
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEI…
Sklar Instruments
Moderate Jan 22, 2025
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STE…
Sklar Instruments
Moderate Jan 22, 2025
McKesson Cardiology Hemo software
A L I Technologies Ltd
Moderate Jan 22, 2025
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
IsoTis OrthoBiologics, Inc.
Moderate Jan 22, 2025
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Augustine Temperature Management, LLC
Moderate Jan 22, 2025
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); …
Sklar Instruments
Moderate Jan 22, 2025
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
DRG International, Inc.
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
Sklar Instruments
Moderate Jan 22, 2025
8MM,CADIERE FORCEPS,IS4000 REF 471049
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PG…
Cardinal Health 200, LLC
Critical Jan 22, 2025
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Baxter Healthcare Corporation
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RE…
Sklar Instruments
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPE…
Sklar Instruments
Moderate Jan 22, 2025
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X …
ev3 Inc
Moderate Jan 22, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Appl…
QUIDEL ORTHO
Moderate Jan 22, 2025
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Cook Biotech, Inc.
Moderate Jan 22, 2025
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLAST…
Cardinal Health 200, LLC
Moderate Jan 22, 2025
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Cook Biotech, Inc.
Critical Jan 22, 2025
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Boston Scientific Corporation
Moderate Jan 22, 2025
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"…
Sklar Instruments
Moderate Jan 22, 2025
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
CareFusion 303, Inc.
Moderate Jan 22, 2025
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to p…
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
IsoTis OrthoBiologics, Inc.
Moderate Jan 22, 2025
8MM,FORCE BIPOLAR,IS4000 REF 471405
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of …
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Sklar Instruments
Critical Jan 22, 2025
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Trokamed GmbH
Moderate Jan 22, 2025
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo…
Augustine Temperature Management, LLC