Category

Surgical Devices Recalls

3,817 surgical devices recalls on record from CPSC, FDA, and USDA.

3,817 recalls
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE ...
Surgical Devices·3,020 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No...
Surgical Devices·260 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular...
Surgical Devices·80 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66 The Transpac Disposable Straight ...
Surgical Devices·430 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
BIFURCATED TRANSPAC¿ 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No. 46063-34 The Transpac Disposable Straight Pressure Tra...
Surgical Devices·120 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ 4 kit w/72" Macrodrip¿ Admin Set, Item No. 46099-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravas...
Surgical Devices·50 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No. 42582-08 The Transpac Disposable Straight Pressure ...
Surgical Devices·2,310 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO¿ FLUSHES, MACRODRIP (POLE MOUNT), Item No. 46101-3...
Surgical Devices·30 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05 The Tra...
Surgical Devices·1,740 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42652-05...
Surgical Devices·740 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRO...
Surgical Devices·200 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05 The Transpac Disposable Straig...
Surgical Devices·17,420 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush Device, Needleless Valves, Red, Blue and Yellow Str...
Surgical Devices·60 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transdu...
Surgical Devices·75 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, Item No. 46072-51 The Transpac Disposable Straight Pressure T...
Surgical Devices·10 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ...
Surgical Devices·50 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extra...
Surgical Devices·100 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-91 The Transpac Disposable Straight Pressure Transducer ...
Surgical Devices·440 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo¿ Flush Devices, Macrodrip (Pole Mount), Item No. 0...
Surgical Devices·130 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressu...
Surgical Devices·110 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular...
Surgical Devices·60 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The Transpac Disposable Straight Pressure Transducer (...
Surgical Devices·30 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The Transpac Disposable Straight Pressure Transducer (DSPT) i...
Surgical Devices·20 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable...
Surgical Devices·2,640 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac Disposable Straight Pressure Transdu...
Surgical Devices·660 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-03 The Trans...
Surgical Devices·275 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure Transducer (DSPT) ...
Surgical Devices·160 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS The Transpac Disposable S...
Surgical Devices·710 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRO...
Surgical Devices·280 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Ite...
Surgical Devices·260 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The Transpac Disposable Straight Pressure Transducer (DSPT) i...
Surgical Devices·130 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), It...
Surgical Devices·730 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUSH, Item No. 42582-09 The Transpac Disposable...
Surgical Devices·520 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer...
Surgical Devices·130 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight P...
Surgical Devices·105 affected·Sep 27, 2016
High RiskFDA
Medtronic Navigation, Inc.-littleton
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging ...
Surgical Devices·14 affected·Sep 22, 2016
High RiskFDA
Stryker Sustainability Solutions
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet sys...
Surgical Devices·1,695,760 affected·Sep 19, 2016
CriticalFDA
Vascular Solutions, Inc.
Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access cathet...
Surgical Devices·11,670 affected·Sep 16, 2016
CriticalFDA
Vascular Solutions, Inc.
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter ...
Surgical Devices·11,670 affected·Sep 16, 2016
CriticalFDA
Vascular Solutions, Inc.
Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual ac...
Surgical Devices·11,670 affected·Sep 16, 2016
High RiskFDA
Greatbatch Medical
Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Mic...
Surgical Devices·23,075 affected·Sep 8, 2016
High RiskFDA
Argon Medical Devices, Inc
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through th...
Surgical Devices·200 affected·Sep 8, 2016
High RiskFDA
Trilliant Surgical Ltd.
Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 ...
Surgical Devices·11 affected·Sep 2, 2016
High RiskFDA
Arrow International Inc
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Ar...
Surgical Devices·330 affected·Sep 2, 2016
High RiskFDA
Medtronic Navigation, Inc.
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouc...
Surgical Devices·100 affected·Sep 1, 2016
High RiskFDA
Medtronic Navigation, Inc.
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches...
Surgical Devices·100 affected·Sep 1, 2016
High RiskFDA
Ldr Spine Usa, Inc.
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the RO...
Surgical Devices·24 affected·Aug 29, 2016
High RiskFDA
Trimed Inc
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm t...
Surgical Devices·30 affected·Aug 29, 2016