Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Medtronic Navigation, Inc.
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734...
Medical Devices·2,346 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·67 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·109 affected·Sep 14, 2015
RecallFDA
Acumedia Manufacturers, Inc.
Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological cult...
Medical Devices·16 affected·Sep 11, 2015
High RiskFDA
Olympus Corporation Of The Americas
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and ...
Medical Devices·31,060 affected·Sep 11, 2015
High RiskFDA
Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (kn...
Medical Devices·603 affected·Sep 10, 2015
High RiskFDA
Beckman Coulter Inc.
MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quant...
Medical Devices·5,138 affected·Sep 10, 2015
High RiskFDA
Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (kn...
Medical Devices·1,287 affected·Sep 10, 2015
High RiskFDA
Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (kn...
Medical Devices·1,347 affected·Sep 10, 2015
High RiskFDA
Ergosafe Products, Llc (dba) Prism Medical
Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.
Medical Devices·1,721 affected·Sep 8, 2015
High RiskFDA
Ergosafe Products, Llc (dba) Prism Medical
Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lif...
Medical Devices·561 affected·Sep 8, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both prim...
Medical Devices·7,488 affected·Sep 8, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Synthes (usa) Products Llc
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Medical Devices·1,550 affected·Sep 3, 2015
High RiskFDA
Bausch & Lomb Inc Irb
BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available i...
Medical Devices·99,260 affected·Sep 3, 2015
High RiskFDA
Summit Medical, Inc.
AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation,...
Medical Devices·9 affected·Sep 3, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) ...
Medical Devices·7 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M...
Medical Devices·348 affected·Aug 31, 2015
High RiskFDA
Pyng Medical Corporation
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATRespond...
Medical Devices·6,728 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) ...
Medical Devices·68 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) ...
Medical Devices·6 affected·Aug 31, 2015
High RiskFDA
Elekta, Inc.
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy ...
Medical Devices·1,440 affected·Aug 31, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattac...
Medical Devices·105,882 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
Medical Devices·0 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) ...
Medical Devices·12 affected·Aug 31, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, an...
Medical Devices·79 affected·Aug 31, 2015
High RiskFDA
B. Braun Medical, Inc.
Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
Medical Devices·433 affected·Aug 27, 2015
High RiskFDA
Zimmer, Inc.
Zimmer Guide Wires for orthopedic procedures.
Medical Devices·112,568 affected·Aug 27, 2015
High RiskFDA
Viewray Incorporated
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesion...
Medical Devices·4 affected·Aug 27, 2015
High RiskFDA
Cardinal Health
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purpose...
Medical Devices·34 affected·Aug 25, 2015
High RiskFDA
Collagen Matrix Inc
NuOSS Cancellous Intended for use in dental surgery.
Medical Devices·171 affected·Aug 25, 2015
High RiskFDA
Sterilmed, Inc.
Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106,...
Medical Devices·43 affected·Aug 24, 2015
High RiskFDA
Perkin Elmer Life Sciences Inc
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laborator...
Medical Devices·6 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customize...
Medical Devices·5 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are ma...
Medical Devices·30 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufacture...
Medical Devices·6 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactu...
Medical Devices·19 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufacture...
Medical Devices·15 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactu...
Medical Devices·17 affected·Aug 24, 2015
High RiskFDA
Teleflex Medical
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Medical Devices·233,641 affected·Aug 24, 2015
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakene...
Medical Devices·9,805 affected·Aug 20, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Medical Devices·21 affected·Aug 18, 2015
High RiskFDA
Medtronic Perfusion Systems
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, H...
Medical Devices·1,594 affected·Aug 18, 2015
High RiskFDA
Toshiba American Medical Systems Inc
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Medical Devices·4 affected·Aug 14, 2015