Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery Ml DR X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima CT540 X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Medacta Usa Inc
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Medical Devices·4 affected·May 19, 2017
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery IQ X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Medical Devices·17,657 affected·May 17, 2017
High RiskFDA
Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by...
Medical Devices·9 affected·May 16, 2017
High RiskFDA
Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage...
Medical Devices·9 affected·May 16, 2017
High RiskFDA
Perkinelmer Life Sciences, Inc.
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Mu...
Medical Devices·241 affected·May 15, 2017
High RiskFDA
Biomerieux, Inc.
VIDAS Testosterone, Ref 30418
Medical Devices·742 affected·May 15, 2017
High RiskFDA
Boston Scientific Corporation
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devi...
Medical Devices·3 affected·May 15, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to ...
Medical Devices·115 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to trea...
Medical Devices·184 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat ...
Medical Devices·153 affected·May 12, 2017
High RiskFDA
Terumo Cardiovascular Systems Corp
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmo...
Medical Devices·30 affected·May 12, 2017
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive ...
Medical Devices·7,750 affected·May 11, 2017
High RiskFDA
Teleflex Medical
Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods t...
Medical Devices·21,690 affected·May 11, 2017
High RiskFDA
Medtronic Navigation, Inc.
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Medical Devices·108 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code...
Medical Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
Medical Devices·0 affected·May 10, 2017
High RiskFDA
Teleflex Medical
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Medical Devices·1,150 affected·May 9, 2017
High RiskFDA
Arrow International Inc
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and ...
Medical Devices·27,485 affected·May 9, 2017
High RiskFDA
Beckman Coulter Inc.
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Medical Devices·249,597 affected·May 9, 2017
High RiskFDA
Cook Inc.
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Medical Devices·4,369 affected·May 9, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication,...
Medical Devices·47 affected·May 8, 2017
RecallFDA
Beekley Corporation
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Medical Devices·104 affected·May 8, 2017
High RiskFDA
Ge Healthcare, Llc
Infant Warmer System (IWS)
Medical Devices·34,986 affected·May 5, 2017
High RiskFDA
Innovasis, Inc
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4....
Medical Devices·21 affected·May 5, 2017
CriticalFDA
Philips Electronics North America Corporation
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
Medical Devices·9,120 affected·May 4, 2017
High RiskFDA
Medtronic
SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
CUSTOM SUTURE PACK; Item Number: US1540 and US1614
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Cook Inc.
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the...
Medical Devices·10,415 affected·May 3, 2017
High RiskFDA
Medtronic
Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 17...
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
USPACK-SUTURE KIT; Item Number: US1672
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON*...
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECU...
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Ge Healthcare, Llc
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Medical Devices·3,448 affected·May 2, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Medical Devices·151 affected·May 2, 2017
High RiskFDA
Zimmer Biomet, Inc.
FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32...
Medical Devices·24,969 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Medical Devices·445 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNI...
Medical Devices·1,707 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 14...
Medical Devices·510 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MM...
Medical Devices·27,279 affected·Apr 28, 2017
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transfe...
Medical Devices·2,718 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Medical Devices·24 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32C...
Medical Devices·1,499 affected·Apr 28, 2017
High RiskFDA
Abbvie Inc.
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Medical Devices·3,331 affected·Apr 27, 2017