Browse

All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Windstone Medical Packaging, Inc.
Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
Medical Devices·58 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Cardiac Devices·40 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room
Medical Devices·288 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the...
Surgical Devices·7,904 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
Medical Devices·268 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in hospital operating room
Medical Devices·227 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room
Medical Devices·160 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room
Medical Devices·123 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on th...
Surgical Devices·164 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospita...
Medical Devices·0 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in hospital operating room
Medical Devices·18 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·630 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
Medical Devices·115 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for ge...
Medical Devices·1,528 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS23...
Medical Devices·8,132 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·20 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on t...
Surgical Devices·26 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used for general surgery in hospital operating room
Medical Devices·56 affected·Apr 22, 2015
High RiskFDA
Biomet, Inc.
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Medical Devices·27 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·186 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·1,233 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on t...
Surgical Devices·872 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room
Medical Devices·114 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible...
Surgical Devices·832 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the l...
Surgical Devices·181 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on...
Surgical Devices·24 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing cover light handle soft, RX. The responsible f...
Surgical Devices·296 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on ...
Surgical Devices·40 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
Medical Devices·54 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing cover light handle soft, RX. The responsible fir...
Surgical Devices·92 affected·Apr 22, 2015
High RiskFDA
Alvogen, Inc
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 0705...
Oral Drugs·13,392 affected·Apr 21, 2015
High RiskFDA
Spacelabs Healthcare Inc
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intend...
Medical Devices·1,973 affected·Apr 21, 2015
High RiskFDA
Hitachi America, Ltd., Power Systems Division
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliv...
Medical Devices·3 affected·Apr 21, 2015
High RiskFDA
Depuy Spine, Inc.
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable):...
Medical Devices·183 affected·Apr 21, 2015
High RiskFDA
Stradis Healthcare, Llc.
Lima Pack - contains Devon Light Glove Used during surgery
Medical Devices·2 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Mississippi Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Arthroscopy Pack - contains Devon Light Glove Used during surgery
Medical Devices·1 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
Medical Devices·9 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Admi...
Medical Devices·50 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Shoulder Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: ...
Medical Devices·600 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
Medical Devices·15 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Vasc Custom Kit - contains Devon Light Glove Used during surgery
Medical Devices·3 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Skin and Vein Pack - contains Devon Light Glove Used during surgery
Medical Devices·3 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery
Surgical Devices·4 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Head & Neck Pack - contains Devon Light Glove Used during surgery
Medical Devices·2 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Blepharoplasty Pack - contains Devon Light Glove Used during surgery
Medical Devices·1 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Bl...
Medical Devices·900 affected·Apr 20, 2015