FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 21 of 520
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Baxter Healthcare Corporation
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version:…
Dexcom, Inc.
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Softwar…
RAYSEARCH LABORATORIES AB
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left…
Boston Scientific Corporation
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. …
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATC…
Boston Scientific Corporation
Micro Joystick R-net. Electrical wheelchair component.
mo-Vis BVBA
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(…
Reflexion Medical, Inc.
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400…
Physio-Control, Inc.
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Softwa…
RAYSEARCH LABORATORIES AB
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device…
Merge Healthcare, Inc.
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version:…
Dexcom, Inc.
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Preat Corp
FloPatch FP120, REF: FP120-FOT01-005
Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoass…
Bio-Rad Laboratories, Inc.
TRANSDUCER L12-5 Transducer Probe
Philips Ultrasound, Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, …
American Contract Systems Inc
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Orascoptic Surgical Acuity
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTO…
MEDLINE INDUSTRIES, LP - Northfield
C6-2 Transducer Probe
Philips Ultrasound, Inc
L12-5 38mm Transducer Probe
Philips Ultrasound, Inc
C8-4v Transducer Probe
Philips Ultrasound, Inc
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
MAQUET GMBH
L9-3 Transducer Probe
Philips Ultrasound, Inc
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provide…
MEDLINE INDUSTRIES, LP - Northfield
X7-2 Transducer Probe
Philips Ultrasound, Inc
GE HealthCare OEC 9900 Elite C-arm Systems.
GE Medical Systems, LLC
Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massag…
Zhejiang Luyao Electronics Technology Co., Ltd.
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808;…
Tandem Diabetes Care, Inc.
S9-2 Transducer Probe
Philips Ultrasound, Inc
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210R…
MEDLINE INDUSTRIES, LP - Northfield
C8-5 Transducer Probe
Philips Ultrasound, Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY P…
American Contract Systems Inc
mC7-2 Transducer Probe
Philips Ultrasound, Inc
C5-2 Lumify Transducer Probe
Philips Ultrasound, Inc
Spectrum IQ Infusion Pump, Product Code 3570009
Baxter Healthcare Corporation
GE HealthCare OEC 9800.
GE Medical Systems, LLC
X6-1 Transducer Probe
Philips Ultrasound, Inc
C9-3v Transducer Probe
Philips Ultrasound, Inc
L12-4 Transducer Probe
Philips Ultrasound, Inc
BP10-5ec Transducer Probe
Philips Ultrasound, Inc
SCNHD LA L7-4 HDI Transducer Probe
Philips Ultrasound, Inc
L8-4 Transducer Probe
Philips Ultrasound, Inc
7.5MHZ Endo Transducer Probe
Philips Ultrasound, Inc
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
Orascoptic Surgical Acuity
L10-4LAP Transducer Probe
Philips Ultrasound, Inc
C10-4ec Transducer Probe
Philips Ultrasound, Inc
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and N…
THOR Photomedicine Ltd
X5-1 Transducer Probe
Philips Ultrasound, Inc