Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 21 of 548
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Softwar…
RAYSEARCH LABORATORIES AB
FDA Devices Critical Sep 10, 2025
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WA…
Boston Scientific Corporation
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software V…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Sep 10, 2025
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
ICU Medical Inc.
FDA Devices Moderate Sep 10, 2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Medtronic MiniMed, Inc.
FDA Devices Critical Sep 10, 2025
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Baxter Healthcare Corporation
FDA Devices Moderate Sep 10, 2025
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated…
Physio-Control, Inc.
FDA Devices Critical Sep 10, 2025
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left …
Boston Scientific Corporation
FDA Devices Moderate Sep 10, 2025
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit co…
ICU Medical Inc.
FDA Devices Moderate Sep 10, 2025
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-0000…
Physio-Control, Inc.
FDA Devices Critical Sep 10, 2025
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Vers…
Dexcom, Inc.
FDA Devices Moderate Sep 10, 2025
MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational pr…
CARIS LIFE SCIENCES
FDA Devices Moderate Sep 10, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
ICU Medical Inc.
FDA Devices Critical Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Medtronic Perfusion Systems
FDA Devices Moderate Sep 10, 2025
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grad…
Integra LifeSciences Corp. (NeuroSciences)
FDA Devices Moderate Sep 10, 2025
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
ICU Medical Inc.
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2,…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Sep 10, 2025
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY…
Integra LifeSciences Corp. (NeuroSciences)
FDA Devices Critical Sep 10, 2025
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATC…
Boston Scientific Corporation
FDA Devices Critical Sep 10, 2025
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Baxter Healthcare Corporation
FDA Devices Critical Sep 10, 2025
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version:…
Dexcom, Inc.
FDA Devices Moderate Sep 10, 2025
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
FDA Devices Critical Sep 10, 2025
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left…
Boston Scientific Corporation
FDA Devices Moderate Sep 10, 2025
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.
FDA Devices Critical Sep 10, 2025
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
FDA Devices Critical Sep 10, 2025
Micro Joystick R-net. Electrical wheelchair component.
mo-Vis BVBA
FDA Devices Moderate Sep 10, 2025
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.
FDA Devices Moderate Sep 10, 2025
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400…
Physio-Control, Inc.
FDA Devices Moderate Sep 10, 2025
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
FDA Devices Moderate Sep 10, 2025
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.
FDA Devices Critical Sep 10, 2025
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version:…
Dexcom, Inc.
FDA Devices Moderate Sep 10, 2025
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Preat Corp
FDA Devices Low Sep 10, 2025
FloPatch FP120, REF: FP120-FOT01-005
Flosonics Medical (R/A 1929803 ONTARIO CORP.)
FDA Devices Moderate Sep 10, 2025
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.
FDA Devices Moderate Sep 10, 2025
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.
CPSC Moderate Sep 4, 2025
StopBox USA Recalls AR-15 Chamber Lock Pros Due to Risk of Serious Injury and Death
StopBox USA, of Spokane Valley, Washington
FDA Devices Low Sep 3, 2025
TRANSDUCER L12-5 Transducer Probe
Philips Ultrasound, Inc
FDA Devices Moderate Sep 3, 2025
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
FDA Devices Moderate Sep 3, 2025
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Orascoptic Surgical Acuity
FDA Devices Moderate Sep 3, 2025
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTO…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Low Sep 3, 2025
C6-2 Transducer Probe
Philips Ultrasound, Inc
FDA Devices Low Sep 3, 2025
L12-5 38mm Transducer Probe
Philips Ultrasound, Inc
FDA Devices Low Sep 3, 2025
C8-4v Transducer Probe
Philips Ultrasound, Inc
FDA Devices Moderate Sep 3, 2025
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
MAQUET GMBH
FDA Devices Low Sep 3, 2025
L9-3 Transducer Probe
Philips Ultrasound, Inc
FDA Devices Moderate Sep 3, 2025
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
FDA Devices Low Sep 3, 2025
X7-2 Transducer Probe
Philips Ultrasound, Inc
FDA Devices Moderate Sep 3, 2025
GE HealthCare OEC 9900 Elite C-arm Systems.
GE Medical Systems, LLC
FDA Devices Moderate Sep 3, 2025
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.
FDA Devices Critical Sep 3, 2025
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.