Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 226 of 548
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 10010…
Microvention, Inc.
FDA Devices Moderate Mar 4, 2020
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506…
St Jude Medical, Cardiac Rhythm Management Division
FDA Devices Moderate Mar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100…
Microvention, Inc.
FDA Devices Moderate Mar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, …
Microvention, Inc.
FDA Devices Moderate Mar 4, 2020
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clini…
Randox Laboratories, Limited
FDA Devices Low Mar 4, 2020
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Theralase Inc.
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
Biomet 3i, LLC
FDA Devices Low Mar 4, 2020
TLC-2000 Therapeutic Medical Laser System
Theralase Inc.
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be u…
Philips North America, LLC
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femora…
Exactech, Inc.
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-0031…
Microvention, Inc.
FDA Devices Low Mar 4, 2020
TLC-2000 Therapeutic Medical Laser System
Theralase Inc.
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
ulrich medical USA Inc
FDA Devices Moderate Mar 4, 2020
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Cook Inc.
FDA Devices Low Mar 4, 2020
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extrac…
LivaNova USA Inc.
CPSC Moderate Feb 27, 2020
Lennox Industries Recalls Ductless Heat Pumps Due to Fire Hazard
FDA Devices Critical Feb 26, 2020
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. …
Philips Respironics, Inc.
FDA Devices Moderate Feb 26, 2020
Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
Arrow International Inc
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation…
Covidien LLC
FDA Devices Moderate Feb 26, 2020
Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing oste…
Nobel Biocare Usa Llc
FDA Devices Moderate Feb 26, 2020
Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
Arrow International Inc
FDA Devices Critical Feb 26, 2020
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. T…
Philips Respironics, Inc.
FDA Devices Moderate Feb 26, 2020
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative …
Abbott Point Of Care Inc.
FDA Devices Critical Feb 26, 2020
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The v…
Philips Respironics, Inc.
FDA Devices Moderate Feb 26, 2020
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
TELEFLEX MEDICAL INC
FDA Devices Moderate Feb 26, 2020
Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteot…
Nobel Biocare Usa Llc
FDA Devices Moderate Feb 26, 2020
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Feb 26, 2020
Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteot…
Nobel Biocare Usa Llc
FDA Devices Moderate Feb 26, 2020
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
The Binding Site Group, Ltd.
FDA Devices Critical Feb 26, 2020
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. T…
Philips Respironics, Inc.
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or liga…
Covidien LLC
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation a…
Covidien LLC
FDA Devices Critical Feb 26, 2020
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is no…
Abbott Vascular
FDA Devices Critical Feb 26, 2020
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated …
Abbott Vascular
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation an…
Covidien LLC
FDA Devices Moderate Feb 26, 2020
PICC Set- PR-35052-HPHNM
Arrow International Inc
FDA Devices Moderate Feb 26, 2020
Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to …
Nobel Biocare Usa Llc
FDA Devices Moderate Feb 26, 2020
SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Ormco/Sybronendo
FDA Devices Moderate Feb 26, 2020
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to imp…
Nobel Biocare Usa Llc
FDA Devices Moderate Feb 26, 2020
Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies fo…
Nobel Biocare Usa Llc