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.
- Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter…
FDA Device · Class II · 2019-11-27 · Cook - Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter…
FDA Device · Class II · 2019-11-27 · Cook - Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter…
FDA Device · Class II · 2019-11-27 · Cook - Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter…
FDA Device · Class II · 2019-11-27 · Cook - Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter…
FDA Device · Class II · 2019-11-27 · Cook - Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter…
FDA Device · Class II · 2019-11-27 · Cook - GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Us…
FDA Device · Class II · 2019-11-27 · Applied Medical Resources - Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter…
FDA Device · Class II · 2019-11-27 · Cook - Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgica…
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical - Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter…
FDA Device · Class II · 2019-11-27 · Cook - NOSEBLEED TRAY Kit Code: MNS3885
FDA Device · Class II · 2019-11-27 · Centurion Medical Products - MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
FDA Device · Class II · 2019-11-27 · Amd Medicom - TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA
FDA Device · Class II · 2019-11-20 · Trimed - Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F…
FDA Device · Class II · 2019-11-20 · Canon Medical System Usa - ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
FDA Device · Class II · 2019-11-20 · Orthofix Srl - LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur includin…
FDA Device · Class II · 2019-11-20 · Smith And Nephew - Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
FDA Device · Class II · 2019-11-20 · Implant Direct Sybron Manufacturing - TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA
FDA Device · Class II · 2019-11-20 · Trimed - ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
FDA Device · Class II · 2019-11-20 · Orthofix Srl - Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner
FDA Device · Class II · 2019-11-20 · Siemens Medical Solutions Usa - ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
FDA Device · Class II · 2019-11-20 · Orthofix Srl - CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard…
FDA Device · Class II · 2019-11-20 · Avanos Medical - TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD
FDA Device · Class II · 2019-11-20 · Trimed - ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
FDA Device · Class II · 2019-11-20 · Orthofix Srl - MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T…
FDA Device · Class II · 2019-11-20 · Synthes Usa Products - Visual-ICE Cryoablation System, FPRCH6000
FDA Device · Class II · 2019-11-20 · Galil Medical - ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856…
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
FDA Device · Class II · 2019-11-20 · Orthofix Srl - Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381)
FDA Device · Class II · 2019-11-20 · Cadence Science - ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)1803256…
FDA Device · Class II · 2019-11-20 · Orthofix Srl - RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066
FDA Device · Class III · 2019-11-20 · Randox Laboratories - ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)1803…
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
FDA Device · Class II · 2019-11-20 · Orthofix Srl - Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505…
FDA Device · Class II · 2019-11-20 · Tornier - ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
FDA Device · Class II · 2019-11-20 · Orthofix Srl - TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tu…
FDA Device · Class II · 2019-11-20 · Trimed - ProtectIV¿ Plus Safety IV Catheter, sterile
FDA Device · Class II · 2019-11-20 · Smiths Medical Asd - ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
FDA Device · Class II · 2019-11-20 · Orthofix Srl - Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental I…
FDA Device · Class II · 2019-11-20 · Implant Direct Sybron Manufacturing - ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)180542425109…
FDA Device · Class II · 2019-11-20 · Orthofix Srl - 2000 Vascular with 30 Degree option
FDA Device · Class II · 2019-11-20 · Heritage Medical Products - ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)180…
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
FDA Device · Class II · 2019-11-20 · Orthofix Srl - TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA
FDA Device · Class II · 2019-11-20 · Trimed - Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
FDA Device · Class II · 2019-11-20 · Basic Reset - EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
FDA Device · Class II · 2019-11-20 · Monarch Medical Technologies - 2.4mm x 2.5 Fluted Pin Pouch
FDA Device · Class II · 2019-11-20 · Exactech - Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electro…
FDA Device · Class II · 2019-11-20 · Carroll Baccari - Universal Sexual Health Testing Kit
FDA Device · Class II · 2019-11-20 · Privapath Diagnostics - Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, M…
FDA Device · Class II · 2019-11-20 · Draegar Medical Systems - CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could…
FDA Device · Class II · 2019-11-20 · Avanos Medical - ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10…
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
FDA Device · Class II · 2019-11-20 · Orthofix Srl - Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electro…
FDA Device · Class II · 2019-11-20 · Carroll Baccari - TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA
FDA Device · Class II · 2019-11-20 · Trimed - ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
FDA Device · Class II · 2019-11-20 · Orthofix Srl - ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
FDA Device · Class II · 2019-11-20 · Orthofix Srl - TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Re…
FDA Device · Class II · 2019-11-20 · Tec Com - 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 - PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 002…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - lmpella CP with Smart Assist, Model Number: 0048-0003
FDA Device · Class II · 2019-11-13 · Abiomed - Grab n Go Opti series VIPR system Model # PRX-9615 - 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 - Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 328550902…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 0…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices - Grab n Go Opti series VIPR system Model # PRX-9653 - 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 - Grab n Go Opti series VIPR system Model # PRX-9646 - 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 - NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 020…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
FDA Device · Class II · 2019-11-13 · Insulet - 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 - PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 002…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-la…
FDA Device · Class II · 2019-11-13 · Ortho Clinical Diagnostics - (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx
FDA Device · Class II · 2019-11-13 · Argon Medical Devices - (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices - Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
FDA Device · Class II · 2019-11-13 · Thermo Fisher Scientific Monterrey - CLS Brevius Stem Kinectiv, hip prosthesis, various sizes
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Grab n Go Opti series VIPR system Model # PRX-9632 - 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 - Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which i…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices - SPIFE Alkaline Hemoglobin Kit, Cat
FDA Device · Class III · 2019-11-13 · Helena Laboratories - 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 - Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732 00877000832 00877000936 00877001036 00877001140 008770012…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315…
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Autoject EI, REF AJ1310
FDA Device · Class II · 2019-11-13 · Owen Mumford Usa - 13 Fr. Trialysis Catheter with Alphacurve
FDA Device · Class II · 2019-11-13 · Becton Dickinson And - Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
FDA Device · Class II · 2019-11-13 · Zimmer Biomet - Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
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)