Category

Surgical Devices Recalls

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

3,817 recalls
RecallFDA
Coopersurgical, Inc.
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Ferti...
Surgical Devices·1 affected·Aug 25, 2016
High RiskFDA
Icu Medical, Inc.
Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access de...
Surgical Devices·476,600 affected·Aug 24, 2016
High RiskFDA
Integra Lifesciences Corp.
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary pa...
Surgical Devices·18 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek p...
Surgical Devices·14 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch,...
Surgical Devices·10 affected·Aug 23, 2016
High RiskFDA
Pentax Of America Inc
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor,...
Surgical Devices·3,436 affected·Aug 15, 2016
High RiskFDA
Pentax Of America Inc
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor,...
Surgical Devices·5,090 affected·Aug 15, 2016
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet opera...
Surgical Devices·19 affected·Aug 12, 2016
High RiskFDA
Deroyal Industries Inc
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
Surgical Devices·26 affected·Aug 11, 2016
High RiskFDA
Deroyal Industries Inc
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Surgical Devices·24 affected·Aug 11, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT)...
Surgical Devices·10 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-4...
Surgical Devices·420 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressu...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole M...
Surgical Devices·60 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrod...
Surgical Devices·980 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) ...
Surgical Devices·70 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Tran...
Surgical Devices·250 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) ...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) i...
Surgical Devices·125 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex...
Surgical Devices·10 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usa...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. ...
Surgical Devices·1,420 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac...
Surgical Devices·10 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 4611...
Surgical Devices·70 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Prod...
Surgical Devices·90 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transpac Disposable Straight Pressure Transduce...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 ...
Surgical Devices·100 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transduc...
Surgical Devices·150 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transd...
Surgical Devices·760 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The ...
Surgical Devices·150 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Ma...
Surgical Devices·4,180 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: The Transpac Disposable Straight Pressure Transducer...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature ...
Surgical Devices·690 affected·Aug 8, 2016
High RiskFDA
Arrow International Inc
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small ve...
Surgical Devices·690 affected·Aug 8, 2016
High RiskFDA
Riverpoint Medical, Llc
Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 6...
Surgical Devices·2,110 affected·Aug 5, 2016
High RiskFDA
Riverpoint Medical, Llc
Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general ...
Surgical Devices·61 affected·Aug 5, 2016
High RiskFDA
C.r. Bard, Inc.
BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design...
Surgical Devices·0 affected·Aug 3, 2016
High RiskFDA
C.r. Bard, Inc.
BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Syringe is avail...
Surgical Devices·452,728 affected·Aug 3, 2016
High RiskFDA
C.r. Bard, Inc.
BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc...
Surgical Devices·0 affected·Aug 3, 2016
High RiskFDA
C.r. Bard, Inc.
BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a ...
Surgical Devices·0 affected·Aug 3, 2016
CriticalFDA
Greatbatch Medical
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100...
Surgical Devices·4,478 affected·Aug 2, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Produ...
Surgical Devices·114,081 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product ...
Surgical Devices·47,989 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Produc...
Surgical Devices·78,063 affected·Jul 29, 2016
High RiskFDA
Zimmer Biomet, Inc.
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be...
Surgical Devices·18 affected·Jul 20, 2016
CriticalFDA
Cardinal Health
BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use ...
Surgical Devices·4,062,511 affected·Jul 20, 2016
High RiskFDA
Bovie Medical Corporation
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, a...
Surgical Devices·95 affected·Jul 18, 2016
High RiskFDA
Bovie Medical Corporation
BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, an...
Surgical Devices·95 affected·Jul 18, 2016