PlainRecalls

Medical Devices Recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

27,372 recalls · Page 68 of 548

FDA Devices Moderate Aug 14, 2024

SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 14, 2024

TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation Syst…

Integra LifeSciences Corp.

FDA Devices Moderate Aug 14, 2024

IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care pro…

Philips North America Llc

FDA Devices Moderate Aug 14, 2024

IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care prof…

Philips North America Llc

FDA Devices Moderate Aug 14, 2024

Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

GE Medical Systems, LLC

FDA Devices Moderate Aug 7, 2024

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appro…

Beckman Coulter Mishima K.K.

FDA Devices Moderate Aug 7, 2024

SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702

Angiodynamics, Inc.

FDA Devices Moderate Aug 7, 2024

SlideView VS200 slide viewer,

EVIDENT SCIENTIFIC INC

FDA Devices Moderate Aug 7, 2024

Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU U…

Medivance Inc.

FDA Devices Moderate Aug 7, 2024

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles:…

BioFire Diagnostics, LLC

FDA Devices Moderate Aug 7, 2024

Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices ar…

Boston Scientific Corporation

FDA Devices Moderate Aug 7, 2024

BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Au…

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 31, 2024

ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the …

Radiometer Medical ApS

FDA Devices Moderate Jul 31, 2024

LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

LINK BIO CORP

FDA Devices Moderate Jul 31, 2024

Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product …

B Braun Medical Inc

FDA Devices Moderate Jul 31, 2024

Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only

Abbott Medical

FDA Devices Moderate Jul 31, 2024

MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jeju…

Avanos Medical, Inc.

FDA Devices Moderate Jul 31, 2024

Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only

Abbott Medical

FDA Devices Moderate Jul 31, 2024

TourniKwik Tourniquet Set (CFN 79012)

Medtronic Perfusion Systems

FDA Devices Moderate Jul 31, 2024

Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative to…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 31, 2024

Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pum…

B Braun Medical Inc

FDA Devices Moderate Jul 31, 2024

Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump …

B Braun Medical Inc

FDA Devices Moderate Jul 31, 2024

BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, s…

Embecta Corp.

FDA Devices Moderate Jul 31, 2024

Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and admin…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 31, 2024

Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow im…

Securitas Healthcare LLC

FDA Devices Moderate Jul 31, 2024

Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only

Abbott Medical

FDA Devices Moderate Jul 31, 2024

Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

Beckman Coulter Inc.

FDA Devices Moderate Jul 31, 2024

Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic an…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 31, 2024

Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.

Beckman Coulter, Inc.

FDA Devices Moderate Jul 24, 2024

Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

Alcon Research LLC

FDA Devices Moderate Jul 24, 2024

OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ …

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

Abbott Medical

FDA Devices Moderate Jul 24, 2024

Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication …

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly

Stryker Sustainability Solutions

FDA Devices Moderate Jul 24, 2024

Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Mo…

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

Cascade IOMAX Cortical Module, REF: 190296-200

Cadwell Industries Inc

FDA Devices Moderate Jul 24, 2024

Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication …

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator

Canadian Hospital Specialties Ltd.

FDA Devices Moderate Jul 24, 2024

Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication…

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only

Abbott Medical

FDA Devices Moderate Jul 24, 2024

Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalo…

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication …

B. Braun Medical, Inc.

FDA Devices Critical Jul 24, 2024

Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure …

Baxter Healthcare Corporation

FDA Devices Moderate Jul 24, 2024

Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catal…

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication …

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication …

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication …

B. Braun Medical, Inc.

FDA Devices Moderate Jul 24, 2024

UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043

Howmedica Osteonics Corp.

FDA Devices Moderate Jul 24, 2024

QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecul…

Qiagen Sciences LLC

FDA Devices Moderate Jul 24, 2024

Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/…

Waldemar Link GmbH & Co. KG (Mfg Site)