Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 224 of 548
FDA Devices Moderate Mar 25, 2020
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products …
TeDan Surgical Innovations LLC
FDA Devices Moderate Mar 25, 2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
FDA Devices Moderate Mar 25, 2020
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Pro…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 25, 2020
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476…
Aesculap Implant Systems LLC
FDA Devices Moderate Mar 25, 2020
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088…
Aesculap Implant Systems LLC
FDA Devices Moderate Mar 25, 2020
OmniDiagnost Eleva System codes 708028 708027
Philips North America, LLC
FDA Devices Moderate Mar 25, 2020
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in h…
Boston Scientific Corporation
FDA Devices Moderate Mar 25, 2020
Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is use…
Deroyal Industries, Inc. Lafollette
FDA Devices Moderate Mar 25, 2020
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Ana…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Mar 25, 2020
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 25, 2020
Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products …
Stryker Corporation
FDA Devices Moderate Mar 25, 2020
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Philips North America, LLC
FDA Devices Critical Mar 25, 2020
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
CME America, LLC
FDA Devices Moderate Mar 25, 2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
FDA Devices Moderate Mar 25, 2020
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M35…
Philips North America, LLC
FDA Devices Moderate Mar 25, 2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
FDA Devices Moderate Mar 25, 2020
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Philips North America, LLC
FDA Devices Moderate Mar 25, 2020
Poly G Integris H5000, System code 72246
Philips North America, LLC
FDA Devices Moderate Mar 25, 2020
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed…
TeDan Surgical Innovations LLC
FDA Devices Moderate Mar 25, 2020
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
The Binding Site Group, Ltd.
FDA Devices Moderate Mar 25, 2020
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Materialise N.V.
FDA Devices Moderate Mar 25, 2020
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to p…
Arthrex, Inc.
FDA Devices Moderate Mar 25, 2020
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN07…
Aesculap Implant Systems LLC
FDA Devices Moderate Mar 25, 2020
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products …
TeDan Surgical Innovations LLC
FDA Devices Moderate Mar 25, 2020
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR0…
Aesculap Implant Systems LLC
CPSC Moderate Mar 19, 2020
C3 Manufacturing Recalls Perfect Descent Climbing Systems Climbing Belay Devices Due to Fall Hazard
C3 Manufacturing LLC, of Littleton, Colo.
FDA Drug Moderate Mar 18, 2020
Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
FDA Drug Moderate Mar 18, 2020
Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
FDA Devices Moderate Mar 18, 2020
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Mar 18, 2020
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Mar 18, 2020
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
FDA Devices Critical Mar 18, 2020
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump Sy…
CME America, LLC
FDA Devices Moderate Mar 18, 2020
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The …
EHOB, Inc.
FDA Devices Moderate Mar 18, 2020
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vial…
Cardinal Health 200, LLC
FDA Devices Moderate Mar 18, 2020
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System …
Nextremity Solutions
FDA Devices Moderate Mar 18, 2020
Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspirati…
Cardinal Health 200, LLC
FDA Devices Moderate Mar 18, 2020
Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796…
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
FDA Devices Moderate Mar 18, 2020
GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
Verathon, Inc.
FDA Devices Moderate Mar 18, 2020
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
BioFire Diagnostics, LLC
FDA Devices Moderate Mar 18, 2020
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Mar 18, 2020
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
FDA Devices Critical Mar 18, 2020
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left v…
Heartware, Inc.
FDA Devices Low Mar 18, 2020
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral ner…
Integra LifeSciences Corp.
FDA Devices Moderate Mar 18, 2020
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Braemar Manufacturing, LLC
FDA Devices Moderate Mar 18, 2020
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from via…
Cardinal Health 200, LLC
FDA Devices Critical Mar 18, 2020
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refract…
Heartware, Inc.
FDA Devices Moderate Mar 18, 2020
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay …
The Binding Site Group, Ltd.
FDA Devices Moderate Mar 18, 2020
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: …
Response Biomedical Corp.
FDA Devices Moderate Mar 18, 2020
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B3…
Medicrea International
FDA Devices Moderate Mar 18, 2020
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
Qiagen Sciences LLC