Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Icu Medical, Inc.
11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(1...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)25...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)24120...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blu...
Surgical Devices·1,100 affected·Jul 1, 2020
High RiskFDA
Medline Industries Inc
ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are inte...
Surgical Devices·680 affected·Jun 30, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff re...
Surgical Devices·137 affected·Jun 24, 2020
High RiskFDA
Argon Medical Devices, Inc
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are...
Surgical Devices·1,000 affected·Jun 19, 2020
High RiskFDA
Wellspect Healthcare (division Of Dentsply Ih Ab)
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
Surgical Devices·0 affected·Jun 17, 2020
High RiskFDA
Wellspect Healthcare (division Of Dentsply Ih Ab)
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Surgical Devices·0 affected·Jun 17, 2020
High RiskFDA
Wellspect Healthcare (division Of Dentsply Ih Ab)
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Surgical Devices·0 affected·Jun 17, 2020
High RiskFDA
Medtronic Xomed, Inc.
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing...
Surgical Devices·673 affected·Jun 12, 2020
High RiskFDA
Intuitive Surgical, Inc.
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Surgical Devices·67 affected·Jun 10, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needle...
Surgical Devices·193 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX...
Surgical Devices·88 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles ar...
Surgical Devices·48 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles...
Surgical Devices·18,440 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are i...
Surgical Devices·656 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needle...
Surgical Devices·79 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are in...
Surgical Devices·7,536 affected·Jun 4, 2020
High RiskFDA
Coopersurgical, Inc.
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
Surgical Devices·2,250 affected·Jun 3, 2020
High RiskFDA
Coltene Whaledent Inc
HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rub...
Surgical Devices·7,206 affected·Jun 3, 2020
High RiskFDA
Coltene Whaledent Inc
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubbe...
Surgical Devices·7,206 affected·Jun 3, 2020
High RiskFDA
Coltene Whaledent Inc
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubb...
Surgical Devices·7,206 affected·Jun 3, 2020
High RiskFDA
Dufner Instrumente Gmbh
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical pr...
Surgical Devices·30 affected·Jun 3, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Thora-Para 5 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis 8 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis 6 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Thora-Para 8 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Prodimed Plastimed Division
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
Surgical Devices·39,800 affected·May 27, 2020
High RiskFDA
Prodimed Plastimed Division
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 ...
Surgical Devices·180 affected·May 27, 2020
High RiskFDA
Prodimed Plastimed Division
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
Surgical Devices·7,220 affected·May 27, 2020
High RiskFDA
Carefusion 2200 Inc
Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
Surgical Devices·358 affected·May 18, 2020
High RiskFDA
Covidien Llc
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery pr...
Surgical Devices·12,610 affected·May 12, 2020
CriticalFDA
Medtronic Vascular Galway Dba Medtronic Ireland
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Surgical Devices·103 affected·May 12, 2020
High RiskFDA
Covidien Llc
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic ...
Surgical Devices·12,610 affected·May 12, 2020
High RiskFDA
Angiodynamics, Inc.
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeuti...
Surgical Devices·119,723 affected·May 4, 2020
High RiskFDA
Angiodynamics, Inc.
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of ...
Surgical Devices·119,723 affected·May 4, 2020
High RiskFDA
Biomet
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Surgical Devices·705 affected·May 1, 2020
High RiskFDA
Biomet
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Surgical Devices·136 affected·May 1, 2020