FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723…
FDA Device · Class I · 2019-11-13 · Medtronic - Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 004…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-…
FDA Device · Class II · 2019-11-13 · Datascope - MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 M…
FDA Device · Class II · 2019-11-13 · Becton Dickinson And - Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, M…
FDA Device · Class I · 2019-11-13 · Medtronic - Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 328555…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical i…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioi…
FDA Device · Class I · 2019-11-13 · Philips Medical Systems Cleveland - Prismaflex Control Unit, software versions below 7.21
FDA Device · Class II · 2019-11-13 · Baxter Healthcare - Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
FDA Device · Class II · 2019-11-13 · Thermo Fisher Scientific Monterrey - PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 4723…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhance…
FDA Device · Class II · 2019-11-13 · Randox Laboratories - Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film
FDA Device · Class I · 2019-11-13 · Medtech Sas - Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 01…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are inten…
FDA Device · Class II · 2019-11-13 · Randox Laboratories - Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical D…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices - Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on t…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices - Hitachi Scenaria Whole-body X-ray CT System
FDA Device · Class II · 2019-11-13 · Hitachi Medical Systems America - Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples
FDA Device · Class III · 2019-11-13 · Biomedical Polymers - Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioi…
FDA Device · Class I · 2019-11-13 · Philips Medical Systems Cleveland - VITROS chemistry Products K+ Slides, Catalog No. 8157596
FDA Device · Class II · 2019-11-13 · Ortho Clinical Diagnostics - Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to…
FDA Device · Class II · 2019-11-13 · Western Scott Fetzer - Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples
FDA Device · Class III · 2019-11-13 · Biomedical Polymers - Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 0058500321…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - CTSTM Essential 8 Medium
FDA Device · Class II · 2019-11-13 · Life Technologies - Prismaflex Control Unit, software versions below 7.21
FDA Device · Class II · 2019-11-13 · Baxter Healthcare - BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 0…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode…
FDA Device · Class II · 2019-11-13 · Ge Healthcare - NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Petfine Auto Injector, REF 3310VET
FDA Device · Class II · 2019-11-13 · Owen Mumford Usa - Prismaflex Control Unit, software versions below 7.21
FDA Device · Class II · 2019-11-13 · Baxter Healthcare - FEMOROTIBIAL/FEMORAL NAIL, various sizes
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 4…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 001…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - LPS-MOB ART SURF IMPL D 9MM
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Connection Screw for NCB Plate, Item No. 0202266002
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 4723580220…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Prismaflex Control Unit, software versions below 7.21
FDA Device · Class II · 2019-11-13 · Baxter Healthcare - Prismaflex Control Unit, software versions below 7.21
FDA Device · Class II · 2019-11-13 · Baxter Healthcare - NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 010…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 001515…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX
FDA Device · Class II · 2019-11-13 · Argon Medical Devices - Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 0…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
FDA Device · Class II · 2019-11-13 · Centurion Medical Products - cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., At…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices - SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
FDA Device · Class II · 2019-11-13 · Pega Medical - Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 020…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 0059790…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 002…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - StemPro¿ MSC SFM CTS"
FDA Device · Class II · 2019-11-13 · Life Technologies - The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and extern…
FDA Device · Class II · 2019-11-13 · Livanova Usa - Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators
FDA Device · Class I · 2019-11-13 · Teleflex Morrisville - CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 004…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 4…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry,…
FDA Device · Class II · 2019-11-13 · Ortho Clinical Diagnostics - CardioLab/ComboLab Recording Systems
FDA Device · Class II · 2019-11-06 · Ge Healthcare - DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
FDA Device · Class II · 2019-11-06 · Valeritas - Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: pr…
FDA Device · Class II · 2019-11-06 · Stryker Neurovascular - PORT ACCESS INFUSION KIT - 1" NEEDLE Product Code: DYNDC2817
FDA Device · Class II · 2019-11-06 · Centurion Medical Products - BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
FDA Device · Class II · 2019-11-06 · Becton Dickinson And - Maintenance Flush Kit/Blood Draw Product Code: DT19335
FDA Device · Class II · 2019-11-06 · Centurion Medical Products - Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
FDA Device · Class II · 2019-11-06 · Medtronic Cardiac Rhythm And Heart Failure Crhf - EndoWrist Suction Irrigator, Single Use Instrument
FDA Device · Class II · 2019-11-06 · Intuitive Surgical - TherMax Blood Warmer Unit
FDA Device · Class II · 2019-11-06 · Baxter Healthcare - Various products which were contract sterilized
FDA Device · Class II · 2019-11-06 · Anewmed - Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The mo…
FDA Device · Class II · 2019-11-06 · Mindray Ds Usa - DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
FDA Device · Class II · 2019-11-06 · Valeritas - Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: produ…
FDA Device · Class II · 2019-11-06 · Stryker Neurovascular - A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum
FDA Device · Class II · 2019-11-06 · Alto Development - DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02
FDA Device · Class II · 2019-11-06 · Valeritas - DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
FDA Device · Class II · 2019-11-06 · Valeritas - Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product U…
FDA Device · Class II · 2019-11-06 · Stryker Neurovascular - DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
FDA Device · Class II · 2019-11-06 · Valeritas - Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
FDA Device · Class II · 2019-11-06 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
FDA Device · Class I · 2019-11-06 · Ethicon Endo Surgery - Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
FDA Device · Class II · 2019-11-06 · Medtronic Cardiac Rhythm And Heart Failure Crhf - C3 Wave App, v. 2.0.5
FDA Device · Class II · 2019-11-06 · Medical Components - SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box)
FDA Device · Class II · 2019-11-06 · Pajunk - POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Con…
FDA Device · Class II · 2019-11-06 · Pom Medical - Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: prod…
FDA Device · Class II · 2019-11-06 · Stryker Neurovascular - Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use
FDA Device · Class II · 2019-11-06 · Cordis - Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahe…
FDA Device · Class II · 2019-11-06 · Convatec - A&E Medical Thorecon Plating System Kits Model No. 94-1400-04
FDA Device · Class II · 2019-11-06 · Alto Development - Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
FDA Device · Class II · 2019-11-06 · Labstyle Innovations - Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
FDA Device · Class II · 2019-11-06 · Synthes Usa Products - Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Device · Class II · 2019-11-06 · Senseonics - Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-…
FDA Device · Class II · 2019-11-06 · Implant Direct Sybron Manufacturing - Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monit…
FDA Device · Class II · 2019-11-06 · Mindray Ds Usa - Model No. 01-1501-0032 (Child Nail Attachment Bolt)
FDA Device · Class II · 2019-11-06 · Orthopediatrics - SAROS Oxygen System Model 3000
FDA Device · Class II · 2019-11-06 · Caire - SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. ind…
FDA Device · Class II · 2019-11-06 · Livanova Usa
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)