FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 14 of 520
Moderate Nov 5, 2025
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Theater Inc
Moderate Nov 5, 2025
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
ICU Medical, Inc.
Critical Nov 5, 2025
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Sof…
Dexcom, Inc.
Moderate Nov 5, 2025
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
CareFusion 303, Inc.
Moderate Nov 5, 2025
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
ICU Medical, Inc.
Moderate Nov 5, 2025
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
MicroSurgical Technology Inc
Moderate Nov 5, 2025
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Fresenius Kabi USA, LLC
Moderate Nov 5, 2025
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Theater Inc
Moderate Nov 5, 2025
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
ICU Medical, Inc.
Moderate Nov 5, 2025
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
ICU Medical, Inc.
Moderate Nov 5, 2025
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
ICU Medical, Inc.
Critical Nov 5, 2025
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
IMPRIS Imaging Inc
Moderate Nov 5, 2025
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Greiner Bio-One North America, Inc.
Moderate Nov 5, 2025
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
DAYE (ANNE'S DAY LTD)
Moderate Oct 29, 2025
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medline Industries, LP
Moderate Oct 29, 2025
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Oct 29, 2025
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch…
Baxter Healthcare Corporation
Moderate Oct 29, 2025
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 …
Cardinal Health 200, LLC
Moderate Oct 29, 2025
Model Number 40KWFXPLUS.004, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
UIH Technologies LLC
Moderate Oct 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
UIH Technologies LLC
Moderate Oct 29, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube,…
Cardinal Health 200, LLC
Moderate Oct 29, 2025
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, O…
CPM Medical Consultants, LLC.
Moderate Oct 29, 2025
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexc…
Tandem Diabetes Care, Inc.
Moderate Oct 29, 2025
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Oct 29, 2025
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Oct 29, 2025
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
SM_40HF_B_D_VIR3, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
SM_40HF_BDC3, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump…
Cardinal Health 200, LLC
Moderate Oct 29, 2025
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray t…
Wipro GE Healthcare Private Ltd.
Moderate Oct 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
UIH Technologies LLC
Moderate Oct 29, 2025
SHIMADZU RF.004, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
UIH Technologies LLC
Moderate Oct 29, 2025
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Oct 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
UIH Technologies LLC