Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Dynavox Systems Llc
Dynavox T10 Speech Generating Device ( including Batteries)
Medical Devices·4,615 affected·Dec 14, 2017
High RiskFDA
Safe N Simple, Llc
DermaPro Waterproof Silicone Tape, SNS57232
Medical Devices·318 affected·Dec 14, 2017
High RiskFDA
Dynavox Systems Llc
Dynavox T15 Speech Generating Device ( including Batteries)
Medical Devices·307 affected·Dec 14, 2017
High RiskFDA
Kalila Medical
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf ...
Medical Devices·261 affected·Dec 14, 2017
High RiskFDA
Merit Medical Systems, Inc.
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, P...
Medical Devices·60,945 affected·Dec 14, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial...
Medical Devices·127 affected·Dec 14, 2017
High RiskFDA
Covidien Llc
Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads ...
Medical Devices·2,121 affected·Dec 13, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of ...
Medical Devices·0 affected·Dec 13, 2017
High RiskFDA
Ii - Vi Incorporated
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
Medical Devices·323,972 affected·Dec 13, 2017
High RiskFDA
Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
Medical Devices·2 affected·Dec 12, 2017
High RiskFDA
Encore Medical, Lp
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
Medical Devices·2 affected·Dec 12, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT P...
Medical Devices·2 affected·Dec 11, 2017
High RiskFDA
Sanofi Genzyme
Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing...
Medical Devices·12,380 affected·Dec 11, 2017
High RiskFDA
Medical Action Industries Inc
Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel produc...
Medical Devices·31,440 affected·Dec 11, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Medical Devices·22 affected·Dec 11, 2017
High RiskFDA
Heidelberg Engineering
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Medical Devices·382 affected·Dec 8, 2017
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments wit...
Medical Devices·3,357 affected·Dec 8, 2017
High RiskFDA
Zimmer Biomet, Inc.
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Medical Devices·12 affected·Dec 8, 2017
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with...
Medical Devices·3,634 affected·Dec 8, 2017
High RiskFDA
Hitachi Ltd., Medical System Operations Group
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions...
Medical Devices·1 affected·Dec 8, 2017
High RiskFDA
Helena Laboratories, Corp.
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Medical Devices·21 affected·Dec 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/...
Medical Devices·6 affected·Dec 7, 2017
High RiskFDA
Intel-ge Care Innovations Llc
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool...
Medical Devices·1,302 affected·Dec 6, 2017
High RiskFDA
Smiths Medical Asd Inc.
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK...
Medical Devices·1,077 affected·Dec 4, 2017
High RiskFDA
Konica Minolta Medical Imaging Usa, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
Medical Devices·17 affected·Dec 4, 2017
High RiskFDA
Cellavision Ab
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Produc...
Medical Devices·224 affected·Dec 4, 2017
High RiskFDA
Accord Media, Llc
Ultra Renew Plus
Medical Devices·1,040 affected·Dec 4, 2017
High RiskFDA
Konica Minolta Medical Imaging Usa, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 0456014...
Medical Devices·30 affected·Dec 4, 2017
High RiskFDA
Elekta, Inc.
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Inf...
Medical Devices·2,998 affected·Dec 1, 2017
High RiskFDA
Mako Surgical Corporation
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Medical Devices·126 affected·Dec 1, 2017
High RiskFDA
Stryker Sustainability Solutions
3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventin...
Medical Devices·280 affected·Dec 1, 2017
High RiskFDA
Ohmeda Medical
Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purcha...
Medical Devices·1,179 affected·Dec 1, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee ...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SI...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMOR...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (...
Medical Devices·1,023 affected·Nov 29, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (1...
Medical Devices·12 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Hologic, Inc.
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Medical Devices·165 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLE...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC L...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Smiths Medical Asd Inc.
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the r...
Medical Devices·10 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM CO...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT ...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX PO...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM...
Medical Devices·13,227 affected·Nov 29, 2017