Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 170 of 548
FDA Devices Moderate Sep 8, 2021
CombiDiagnost R90 Software Version R1.0 and R1.1
Philips Medical Systems Gmbh, DMC
FDA Devices Moderate Sep 8, 2021
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 1153…
Baxter Healthcare Corporation
FDA Devices Moderate Sep 8, 2021
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simulta…
Versea Diagnostics LLC
FDA Devices Moderate Sep 8, 2021
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in …
DePuy Orthopaedics, Inc.
FDA Devices Moderate Sep 8, 2021
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Covidien, LP
FDA Devices Moderate Sep 8, 2021
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Smiths Medical ASD Inc.
FDA Devices Moderate Sep 8, 2021
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
Covidien, LP
FDA Drug Moderate Sep 1, 2021
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
Eli Lilly & Company
FDA Devices Moderate Sep 1, 2021
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information sys…
Beckman Coulter Inc.
FDA Devices Moderate Sep 1, 2021
OASIS MRI System
Hitachi Healthcare Americas Corporation
FDA Devices Critical Sep 1, 2021
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing comp…
Cardinal Health
FDA Devices Moderate Sep 1, 2021
ECHELON MRI System
Hitachi Healthcare Americas Corporation
FDA Devices Moderate Sep 1, 2021
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional ima…
Philips North America Llc
FDA Devices Critical Sep 1, 2021
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing com…
Cardinal Health
FDA Devices Moderate Sep 1, 2021
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
BioMimetic Therapeutics, LLC
FDA Devices Moderate Sep 1, 2021
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Roche Diabetes Care, Inc.
FDA Devices Moderate Sep 1, 2021
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
DePuy Orthopaedics, Inc.
FDA Devices Moderate Sep 1, 2021
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, …
Philips North America Llc
FDA Devices Moderate Sep 1, 2021
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Produc…
Ethicon Endo-Surgery Inc
FDA Devices Moderate Sep 1, 2021
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, C…
W. L. Gore & Associates Inc.
FDA Devices Critical Sep 1, 2021
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing co…
Cardinal Health
FDA Devices Moderate Sep 1, 2021
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, …
Philips North America Llc
FDA Devices Moderate Sep 1, 2021
ECHELON Oval MRI System
Hitachi Healthcare Americas Corporation
FDA Devices Moderate Sep 1, 2021
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Roche Diabetes Care, Inc.
FDA Devices Moderate Sep 1, 2021
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Pa…
Encore Medical, LP
FDA Devices Moderate Sep 1, 2021
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional…
Philips North America Llc
FDA Devices Moderate Sep 1, 2021
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vascul…
Northeast Scientific Inc.
FDA Devices Moderate Sep 1, 2021
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, …
Philips North America Llc
FDA Devices Moderate Sep 1, 2021
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Roche Diabetes Care, Inc.
FDA Devices Moderate Aug 25, 2021
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Ortho8, Inc.
FDA Devices Moderate Aug 25, 2021
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Delta Med SpA
FDA Devices Moderate Aug 25, 2021
Trilogy Evo Universal, Product number DS2000X11B
Philips Respironics, Inc.
FDA Devices Moderate Aug 25, 2021
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19…
Philips Respironics, Inc.
FDA Devices Moderate Aug 25, 2021
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Boston Scientific Corporation
FDA Devices Moderate Aug 25, 2021
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: …
W L Gore & Associates, Inc.
FDA Devices Moderate Aug 25, 2021
728333 Spectral CT 7500 -Computed Tomography X-ray system
Philips North America Llc
FDA Devices Moderate Aug 25, 2021
728332 IQon Spectral CT-Computed Tomography X-ray system
Philips North America Llc
FDA Devices Moderate Aug 25, 2021
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Delta Med SpA
FDA Devices Moderate Aug 25, 2021
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Philips North America Llc
FDA Devices Moderate Aug 25, 2021
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Delta Med SpA
FDA Devices Moderate Aug 25, 2021
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Philips North America Llc
FDA Devices Moderate Aug 25, 2021
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 …
Teleflex Medical Europe Ltd
FDA Devices Moderate Aug 25, 2021
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Epimed International
FDA Devices Moderate Aug 25, 2021
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
OPTI Medical Systems, Inc
FDA Devices Moderate Aug 25, 2021
RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065…
Teleflex Medical Europe Ltd
FDA Devices Critical Aug 25, 2021
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) …
Cardinal Health 200, LLC
FDA Devices Moderate Aug 25, 2021
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Delta Med SpA
FDA Devices Moderate Aug 25, 2021
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) R…
Delta Med SpA
FDA Devices Moderate Aug 25, 2021
NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
Delta Med SpA
FDA Devices Moderate Aug 25, 2021
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Delta Med SpA