FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 15 of 520
Moderate Oct 29, 2025
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Model Number 40KW-FX.899, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Oct 29, 2025
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly…
Theken Companies LLC
Moderate Oct 29, 2025
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUT…
Becton Dickinson & Co.
Moderate Oct 29, 2025
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
SM_40HF_B_D_VIR3.004, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Model Number 40KWFXPLUS.889, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Critical Oct 29, 2025
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut …
ICU Medical, Inc.
Moderate Oct 29, 2025
Starcam/Camstar; 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 55C, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Oct 29, 2025
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA…
Synthes (USA) Products LLC
Moderate Oct 29, 2025
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
SM_40HF_BDC, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Oct 29, 2025
RADPRO MOBILE, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Cod…
GE Medical Systems, LLC
Critical Oct 29, 2025
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 100043…
Abiomed, Inc.
Moderate Oct 29, 2025
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray t…
Wipro GE Healthcare Private Ltd.
Moderate Oct 29, 2025
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Beckman Coulter, Inc.
Moderate Oct 29, 2025
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UN…
Becton Dickinson & Co.
Moderate Oct 29, 2025
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
SEDECAL SA
Moderate Oct 29, 2025
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Oct 29, 2025
Model Number 40KWMOBILE3.899, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Model Number 40KWFXPLUS.005, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Oct 29, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
Cardinal Health 200, LLC
Moderate Oct 29, 2025
Millenium MPS; 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 80C, Mobile X-ray system
SEDECAL SA
Critical Oct 29, 2025
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Pr…
B BRAUN MEDICAL INC
Moderate Oct 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
UIH Technologies LLC
Moderate Oct 29, 2025
Model Number 40KWFXPLUS.002, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
UIH Technologies LLC
Moderate Oct 29, 2025
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the…
Becton Dickinson & Co.
Moderate Oct 29, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12F…
Cardinal Health 200, LLC
Moderate Oct 29, 2025
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
SEDECAL SA
Moderate Oct 29, 2025
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument To…
Becton Dickinson & Co.
Moderate Oct 22, 2025
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Baxter Healthcare Corporation
Critical Oct 22, 2025
Model Number L211 PROPONENT DR SL MRI Pacemaker
Boston Scientific Corporation
Critical Oct 22, 2025
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Olympus Corporation of the Americas
Critical Oct 22, 2025
Model Number S702, ALTRUA 2 DR SL Pacemaker
Boston Scientific Corporation
Moderate Oct 22, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-i…
Baxter Healthcare Corporation
Moderate Oct 22, 2025
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANG…
American Contract Systems Inc.
Moderate Oct 22, 2025
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
GE Medical Systems, LLC
Critical Oct 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Olympus Corporation of the Americas