FDA (Device enforcement)

11,102 recalls · page 37 of 112

• Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V4952024-11-01
• Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 2024-11-01
• Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH 22024-11-01
• Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL2024-11-01
• Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL2024-11-01
• FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) lase2024-11-01
• Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tan2024-11-01
• FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a compute2024-11-01
• FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a comput2024-11-01
• FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 003829066351812024-11-01
• Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.2024-10-31
• BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 4410072024-10-31
• BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 4408872024-10-31
• BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 4409812024-10-31
• BD COR PX Instrument Version or Model: 443988 Catalog Number: 4439882024-10-31
• BD COR MX Instrument Version or Model: 443989 Catalog Number: 4439892024-10-31
• BD COR GX Instrument Version or Model: 443990 Catalog Number: 4439902024-10-31
• BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 4419162024-10-31
• BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 4441502024-10-31
• BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 4436242024-10-31
• BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 4413852024-10-31
• BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 4422962024-10-31
• BACTEC 9120 System Version or Model: 445570 Catalog Number: 4455702024-10-31
• BACTEC 9240 System Version or Model: 445475 Catalog Number: 4454752024-10-31
• Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)2024-10-31
• EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH1902024-10-31
• Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.02024-10-31
• BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.2024-10-29
• Discovery MR750w 3.0T, whole body magnetic resonance scanner2024-10-28
• SIGNA Architect, Nuclear Magnetic Resonance Imaging System2024-10-28
• SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System2024-10-28
• Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,2024-10-28
• smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP2024-10-28
• smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP2024-10-28
• smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-762024-10-28
• AMS Artificial Urinary Sphincter Control Pump2024-10-28
• AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O2024-10-28
• Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode2024-10-28
• Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.2024-10-28
• ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-15552024-10-25
• Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)2024-10-25
• Galaxy System (GAL-001)2024-10-25
• GE Proteus XR/A radiographic system2024-10-24
• Clean Catch Kit, SKU DYKM1833A; Component No. 5035812024-10-23
• Lab Kit, SKU DYLAB1018; Component No. 5035812024-10-23
• UA KIT, SKU DYKM1690A; Component No. 5035812024-10-23
• URINALYSIS KIT 4, SKU DYLAB1021; Component No. 5035812024-10-23
• URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 5035812024-10-23
• URINE COLLECTION VHC, SKU DYLAB1016; Component No. 5035812024-10-23
• URINE KIT, SKU DYKM1845; Component No. 5035812024-10-23
• URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 5035812024-10-23
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis2024-10-23
• MICRO-X Rover Mobile X-ray System, # MXU-RV192024-10-23
• MICRO-X Rover Mobile X-ray System, # MXU-RV352024-10-22
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis2024-10-21
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis2024-10-21
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis2024-10-21
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis2024-10-21
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis2024-10-21
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis2024-10-21
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis2024-10-21
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis2024-10-21
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis2024-10-21
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis2024-10-21
• JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 1100273572024-10-21
• Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.2024-10-21
• Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 110976352024-10-21
• Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software2024-10-18
• human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.2024-10-18
• Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile2024-10-17
• Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile2024-10-17
• Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile2024-10-17
• Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile2024-10-17
• Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile2024-10-17
• Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.2024-10-16
• Acrobat-i Positioner. Model Number C-XP-5000Z2024-10-16
• Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z2024-10-16
• Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z2024-10-16
• MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector2024-10-16
• MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869; 6) CONT EPID 18G NDL/20G C2024-10-16
• MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH202024-10-16
• MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A2024-10-16
• MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN16442024-10-16
• MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN90242024-10-16
• MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A2024-10-16
• Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable2024-10-15
• Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable2024-10-15
• OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to2024-10-15
• (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.2024-10-15
• (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.2024-10-15
• Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.2024-10-15
• Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.2024-10-15
• Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)2024-10-14
• Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)2024-10-14
• Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)2024-10-14
• Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden cardiac arrest (SCA.)2024-10-14
• Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring2024-10-11
• Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test2024-10-11
• Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph2024-10-11
• Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph2024-10-11