Browse recalls
Issuing authority: US FDA — Medical Devices
- 2023-09-29 · US FDA — Medical DevicesClass II
IRON assay, Reference Numbers 6K95-41 and 6K95-30 - 2023-09-27 · US FDA — Medical DevicesClass II
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix - 2023-09-26 · US FDA — Medical DevicesClass II
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set. - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110IN - 2023-09-26 · US FDA — Medical DevicesClass II
RAPIDPOINT 500 Blood Gas System - 2023-09-26 · US FDA — Medical DevicesClass II
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium- - 2023-09-25 · US FDA — Medical DevicesClass II
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum an - 2023-09-25 · US FDA — Medical DevicesClass II
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial i - 2023-09-25 · US FDA — Medical DevicesClass II
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper - 2023-09-25 · US FDA — Medical DevicesClass III
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. - 2023-09-25 · US FDA — Medical DevicesClass II
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T15 - 2023-09-25 · US FDA — Medical DevicesClass II
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasophary - 2023-09-25 · US FDA — Medical DevicesClass II
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and il - 2023-09-25 · US FDA — Medical DevicesClass II
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endosc - 2023-09-25 · US FDA — Medical DevicesClass II
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and - 2023-09-25 · US FDA — Medical DevicesClass II
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF- - 2023-09-25 · US FDA — Medical DevicesClass II
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-V - 2023-09-25 · US FDA — Medical DevicesClass II
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronch - 2023-09-25 · US FDA — Medical DevicesClass II
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V. - 2023-09-25 · US FDA — Medical DevicesClass II
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and du - 2023-09-25 · US FDA — Medical DevicesClass II
Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and en - 2023-09-22 · US FDA — Medical DevicesClass I
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. - 2023-09-21 · US FDA — Medical DevicesClass I
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System - 2023-09-21 · US FDA — Medical DevicesClass II
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit - 2023-09-21 · US FDA — Medical DevicesClass I
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System - 2023-09-21 · US FDA — Medical DevicesClass II
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 - 2023-09-19 · US FDA — Medical DevicesClass II
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of le - 2023-09-18 · US FDA — Medical DevicesClass II
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, - 2023-09-18 · US FDA — Medical DevicesClass II
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, an - 2023-09-15 · US FDA — Medical DevicesClass I
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Sur - 2023-09-14 · US FDA — Medical DevicesClass II
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System - 2023-09-14 · US FDA — Medical DevicesClass II
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System - 2023-09-13 · US FDA — Medical DevicesClass I
Astral 100 and Astral 150 ventilators - 2023-09-12 · US FDA — Medical DevicesClass II
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains - 2023-09-12 · US FDA — Medical DevicesClass II
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic - 2023-09-12 · US FDA — Medical DevicesClass II
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as w - 2023-09-07 · US FDA — Medical DevicesClass II
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102 - 2023-09-06 · US FDA — Medical DevicesClass II
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 - 2023-09-06 · US FDA — Medical DevicesClass II
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 - 2023-09-06 · US FDA — Medical DevicesClass II
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1 - 2023-09-06 · US FDA — Medical DevicesClass II
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished) - 2023-09-01 · US FDA — Medical DevicesClass II
LAVH, REF BBLV21C - 2023-09-01 · US FDA — Medical DevicesClass II
Robotics Pack SAH, REF SAR530M - 2023-09-01 · US FDA — Medical DevicesClass II
Robotics Pack, REF SJVO56B - 2023-09-01 · US FDA — Medical DevicesClass II
Vasc. Open CVOR SJH, REF SJVO56B - 2023-09-01 · US FDA — Medical DevicesClass II
CVS PCSU SJH, REF SJCV48J - 2023-09-01 · US FDA — Medical DevicesClass II
Pediatric Heart SJH, REF SJPH34K - 2023-09-01 · US FDA — Medical DevicesClass II
Cath Cardiac Pack, REF IHCC03V - 2023-09-01 · US FDA — Medical DevicesClass II
Robotics Pack, REF SSRO22D - 2023-09-01 · US FDA — Medical DevicesClass II
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mic - 2023-09-01 · US FDA — Medical DevicesClass II
Sub Q Recorder Pack, REF BPRC87A - 2023-08-31 · US FDA — Medical DevicesClass II
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 - 2023-08-31 · US FDA — Medical DevicesClass II
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 - 2023-08-30 · US FDA — Medical DevicesClass II
Citrine Triple Quad Mass Spectrometer, Part Number 5063684 - 2023-08-30 · US FDA — Medical DevicesClass II
4500MD Triple Quad Mass Spectrometer, Part Number 5032522 - 2023-08-30 · US FDA — Medical DevicesClass II
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restruct - 2023-08-25 · US FDA — Medical DevicesClass II
Multichem P, Part Code 08P90-10 - 2023-08-25 · US FDA — Medical DevicesClass II
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 - 2023-08-24 · US FDA — Medical DevicesClass II
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used Wit - 2023-08-23 · US FDA — Medical DevicesClass II
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Au - 2023-08-23 · US FDA — Medical DevicesClass II
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 serie - 2023-08-22 · US FDA — Medical DevicesClass II
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam ster - 2023-08-22 · US FDA — Medical DevicesClass II
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of - 2023-08-22 · US FDA — Medical DevicesClass II
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air remova - 2023-08-22 · US FDA — Medical DevicesClass II
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam - 2023-08-22 · US FDA — Medical DevicesClass II
Puritan Bennett Cuff Pressure Manager, REF: 180-03 - 2023-08-22 · US FDA — Medical DevicesClass II
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection o - 2023-08-18 · US FDA — Medical DevicesClass II
Constellation Vision System, REF: 8065751150 - 2023-08-17 · US FDA — Medical DevicesClass II
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Pr - 2023-08-17 · US FDA — Medical DevicesClass II
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implan - 2023-08-17 · US FDA — Medical DevicesClass II
SOZO Bilateral Arm L-Dex Software - 2023-08-16 · US FDA — Medical DevicesClass II
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrilla - 2023-08-16 · US FDA — Medical DevicesClass II
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 - 2023-08-16 · US FDA — Medical DevicesClass II
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 06 - 2023-08-16 · US FDA — Medical DevicesClass II
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0 - 2023-08-16 · US FDA — Medical DevicesClass II
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 - 2023-08-10 · US FDA — Medical DevicesClass II
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19 - 2023-08-10 · US FDA — Medical DevicesClass II
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Alw - 2023-08-10 · US FDA — Medical DevicesClass II
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x. - 2023-08-10 · US FDA — Medical DevicesClass II
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN - 2023-08-10 · US FDA — Medical DevicesClass II
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-56 - 2023-08-10 · US FDA — Medical DevicesClass II
Functional MR V1.0 - 2023-08-07 · US FDA — Medical DevicesClass II
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a cons - 2023-08-07 · US FDA — Medical DevicesClass II
Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bon - 2023-08-07 · US FDA — Medical DevicesClass II
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the us - 2023-08-07 · US FDA — Medical DevicesClass II
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to m - 2023-08-05 · US FDA — Medical DevicesClass II
VITROS XT Chemistry Products ALKP Slides - 2023-08-05 · US FDA — Medical DevicesClass II
VITROS XT Chemistry Products TBIL-ALKP Slides - 2023-08-03 · US FDA — Medical DevicesClass II
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049 - 2023-08-02 · US FDA — Medical DevicesClass II
Incisive CT, software version 5.0 - 2023-08-01 · US FDA — Medical DevicesClass II
GS70H Salus Surgical Table, Product Code 18-071-70 - 2023-07-31 · US FDA — Medical DevicesClass I
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099 - 2023-07-31 · US FDA — Medical DevicesClass I
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099 - 2023-07-31 · US FDA — Medical DevicesClass I
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 - 2023-07-27 · US FDA — Medical DevicesClass II
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS - 2023-07-26 · US FDA — Medical DevicesClass II
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis impla