Browse recalls

Alert level: Class II

1826 indexed recall(s) · page 11 of 19 · All filters →

• 2024-12-18 · US FDA — Medical DevicesClass II
  GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
• 2024-12-18 · US FDA — Medical DevicesClass II
  GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H31
• 2024-12-18 · US FDA — Medical DevicesClass II
  GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
• 2024-12-18 · US FDA — Medical DevicesClass II
  GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401C
• 2024-12-16 · US FDA — Medical DevicesClass II
  Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hyp
• 2024-12-16 · US FDA — Medical DevicesClass II
  Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypo
• 2024-12-12 · US FDA — Medical DevicesClass II
  SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimula
• 2024-12-12 · US FDA — Medical DevicesClass II
  SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimul
• 2024-12-03 · US FDA — Medical DevicesClass II
  UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-b
• 2024-12-02 · US FDA — Medical DevicesClass II
  VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
• 2024-12-02 · US FDA — Medical DevicesClass II
  MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
• 2024-11-26 · US FDA — Medical DevicesClass II
  Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int
• 2024-11-25 · US FDA — Medical DevicesClass II
  GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3)
• 2024-11-25 · US FDA — Medical DevicesClass II
  GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3)
• 2024-11-25 · US FDA — Medical DevicesClass II
  Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
• 2024-11-25 · US FDA — Medical DevicesClass II
  GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3
• 2024-11-22 · US FDA — Medical DevicesClass II
  epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by tra
• 2024-11-22 · US FDA — Medical DevicesClass II
  epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by tra
• 2024-11-22 · US FDA — Medical DevicesClass II
  epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by t
• 2024-11-22 · US FDA — Medical DevicesClass II
  epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by train
• 2024-11-22 · US FDA — Medical DevicesClass II
  epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by tra
• 2024-11-21 · US FDA — Medical DevicesClass II
  The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming
• 2024-11-20 · US FDA — Medical DevicesClass II
  Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
• 2024-11-18 · US FDA — Medical DevicesClass II
  Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac t
• 2024-11-16 · US FDA — Medical DevicesClass II
  Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
• 2024-11-14 · US FDA — Medical DevicesClass II
  BD Pyxis CII Safe ES, REF: 1116-00
• 2024-11-14 · US FDA — Medical DevicesClass II
  BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
• 2024-11-14 · US FDA — Medical DevicesClass II
  BD Pyxis MedStation ES, REF: 323
• 2024-11-13 · US FDA — Medical DevicesClass II
  DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
• 2024-11-12 · US FDA — Medical DevicesClass II
  Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
• 2024-11-11 · US FDA — Medical DevicesClass II
  Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2.
• 2024-11-07 · US FDA — Medical DevicesClass II
  DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
• 2024-11-06 · US FDA — Medical DevicesClass II
  KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
• 2024-11-06 · US FDA — Medical DevicesClass II
  SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
• 2024-11-06 · US FDA — Medical DevicesClass II
  Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU D
• 2024-11-06 · US FDA — Medical DevicesClass II
  DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
• 2024-11-06 · US FDA — Medical DevicesClass II
  FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
• 2024-11-06 · US FDA — Medical DevicesClass II
  Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU
• 2024-11-06 · US FDA — Medical DevicesClass II
  Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed,
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-r
• 2024-11-05 · US FDA — Medical DevicesClass II
  GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
• 2024-11-04 · US FDA — Medical DevicesClass II
  Atellica CI Analyzer. Catalog Numbers: 10947347.
• 2024-10-31 · US FDA — Medical DevicesClass II
  BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
• 2024-10-31 · US FDA — Medical DevicesClass II
  BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
• 2024-10-31 · US FDA — Medical DevicesClass II
  BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
• 2024-10-31 · US FDA — Medical DevicesClass II
  BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
• 2024-10-31 · US FDA — Medical DevicesClass II
  BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
• 2024-10-31 · US FDA — Medical DevicesClass II
  BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
• 2024-10-31 · US FDA — Medical DevicesClass II
  BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
• 2024-10-28 · US FDA — Medical DevicesClass II
  smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
• 2024-10-28 · US FDA — Medical DevicesClass II
  Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnosti
• 2024-10-28 · US FDA — Medical DevicesClass II
  smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
• 2024-10-28 · US FDA — Medical DevicesClass II
  smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
• 2024-10-25 · US FDA — Medical DevicesClass II
  Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy S
• 2024-10-23 · US FDA — Medical DevicesClass II
  MICRO-X Rover Mobile X-ray System, # MXU-RV19
• 2024-10-22 · US FDA — Medical DevicesClass II
  MICRO-X Rover Mobile X-ray System, # MXU-RV35
• 2024-10-14 · US FDA — Medical DevicesClass II
  Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG,
• 2024-10-11 · US FDA — Medical DevicesClass II
  Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
• 2024-10-11 · US FDA — Medical DevicesClass II
  Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
• 2024-10-11 · US FDA — Medical DevicesClass II
  Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
• 2024-10-09 · US FDA — Medical DevicesClass II
  Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
• 2024-10-07 · US FDA — FoodClass II
  Douglas Labs Stress-B-Plus Dietary Supplement, Tablets, 90 tablets per bottle. UPC # 10539 97452, Lot Numbers ,50335944
• 2024-10-04 · US FDA — Medical DevicesClass II
  Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appli
• 2024-10-04 · US FDA — Medical DevicesClass II
  Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgica
• 2024-10-04 · US FDA — Medical DevicesClass II
  Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical a
• 2024-10-04 · US FDA — Medical DevicesClass II
  Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosur
• 2024-10-04 · US FDA — Medical DevicesClass II
  Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosu
• 2024-10-04 · US FDA — Medical DevicesClass II
  Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgi
• 2024-10-03 · US FDA — Medical DevicesClass II
  DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
• 2024-10-03 · US FDA — Medical DevicesClass II
  DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
• 2024-10-03 · US FDA — Medical DevicesClass II
  DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
• 2024-09-30 · US FDA — Medical DevicesClass II
  Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10
• 2024-09-27 · US FDA — Medical DevicesClass II
  AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex Arterial Kit 1/EA, Product Code REF MX7827
• 2024-09-24 · US FDA — Medical DevicesClass II
  smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
• 2024-09-24 · US FDA — Medical DevicesClass II
  epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
• 2024-09-24 · US FDA — Medical DevicesClass II
  medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
• 2024-09-20 · US FDA — Medical DevicesClass II
  Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06

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