Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm...
Medical Devices·52 affected·Dec 9, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 ...
Medical Devices·378 affected·Dec 8, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 ...
Medical Devices·289 affected·Dec 8, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 ...
Medical Devices·200 affected·Dec 8, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and cou...
Medical Devices·47 affected·Dec 8, 2015
High RiskFDA
Compview Medical, Llc
Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to fa...
Medical Devices·10 affected·Dec 4, 2015
High RiskFDA
Steris Corporation
Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow un...
Medical Devices·809 affected·Dec 4, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Ethicon, Inc.
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) Sy...
Medical Devices·96,124 affected·Dec 3, 2015
High RiskFDA
Teleflex Medical
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Medical Devices·2,700 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD,...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Del Medical, Inc.
VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.
Medical Devices·4,000 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, ...
Medical Devices·29,815,600 affected·Dec 3, 2015
CriticalFDA
Medtronic
Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra U...
Medical Devices·2,711 affected·Dec 2, 2015
High RiskFDA
Zimmer Manufacturing B.v.
Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3;...
Medical Devices·179 affected·Dec 2, 2015
High RiskFDA
Biomet, Inc.
Black Mamba Suture Passer
Medical Devices·50 affected·Dec 2, 2015
High RiskFDA
Biomet, Inc.
Green Mamba Suture Passer
Medical Devices·13 affected·Dec 2, 2015
CriticalFDA
Medtronic
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, End...
Medical Devices·364,768 affected·Dec 2, 2015
High RiskFDA
3m Company - Health Care Business
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Medical Devices·167 affected·Dec 1, 2015
High RiskFDA
Microbiologics Inc
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) ...
Medical Devices·8 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining a...
Medical Devices·751 affected·Dec 1, 2015
High RiskFDA
Josnoe Medical, Inc.
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Medical Devices·1,008 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobia...
Medical Devices·2,706 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automat...
Medical Devices·666 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobia...
Medical Devices·284 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining a...
Medical Devices·715 affected·Dec 1, 2015
High RiskFDA
Microbiologics Inc
QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb)...
Medical Devices·541 affected·Dec 1, 2015
High RiskFDA
Aesculap, Inc.
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicat...
Medical Devices·1,232 affected·Nov 30, 2015
High RiskFDA
Acumedia Manufacturers, Inc.
Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the ...
Medical Devices·28 affected·Nov 30, 2015
High RiskFDA
Verathon, Inc.
GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope ...
Medical Devices·448 affected·Nov 30, 2015
High RiskFDA
Verathon, Inc.
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 027...
Medical Devices·2,524 affected·Nov 30, 2015
High RiskFDA
Baxter Healthcare Corp.
Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: ...
Medical Devices·9,600 affected·Nov 30, 2015
High RiskFDA
Baxter Healthcare Corp.
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory t...
Medical Devices·77,136 affected·Nov 30, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Medical Devices·5,569 affected·Nov 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Medical Devices·1,880 affected·Nov 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Medical Devices·5,671 affected·Nov 25, 2015
High RiskFDA
The Anspach Effort, Inc.
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Medical Devices·20 affected·Nov 25, 2015
High RiskFDA
Mako Surgical Corporation
MAKOplasty Hip Array Kit Laminate 150230
Medical Devices·10 affected·Nov 25, 2015
High RiskFDA
Abeon Medical Corporation
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retractio...
Medical Devices·2,570 affected·Nov 25, 2015
High RiskFDA
Kci Usa, Inc.
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home c...
Medical Devices·12,728 affected·Nov 25, 2015
High RiskFDA
Instratek, Incorporated
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Medical Devices·39 affected·Nov 24, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Medical Devices·211 affected·Nov 24, 2015
High RiskFDA
Biomerieux Inc
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant ...
Medical Devices·24 affected·Nov 23, 2015
High RiskFDA
Intuitive Surgical, Inc.
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscop...
Medical Devices·2,624 affected·Nov 23, 2015
High RiskFDA
Zyto Technologies, Inc.
The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the se...
Medical Devices·1,252 affected·Nov 23, 2015
High RiskFDA
Terumo Medical Corp
Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Medical Devices·80,500 affected·Nov 23, 2015
High RiskFDA
Intuitive Surgical, Inc.
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope...
Medical Devices·2,624 affected·Nov 23, 2015