232 results
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Sources: EU EUDAMED, US FDA
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Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IKD·February 22, 2019
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
FDA Recall
Open, Classified
·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020
Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code KDC·June 22, 2004
DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·March 1, 2010
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips
FDA Recall
Terminated
·LW Scientific, Inc.·Product code JQC·February 6, 2019
LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes
FDA Recall
Terminated
·LW Scientific, Inc.·Product code JQC·February 6, 2019
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)
FDA Recall
Terminated
·LW Scientific, Inc.·Product code JQC·February 6, 2019
Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" "***REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" Products subject to recall: REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK, Lot 622120. REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 1/PK, Lot 622120. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code NDJ·November 8, 2010
Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" "***REF: 99-7204***"1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" REF: 01-7204 1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG, Lot 202450. REF: 99-7204 "1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG, Lot 202450. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code NDJ·November 8, 2010
NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in the law enforcement market or veterinary market.
FDA Recall
Terminated
·E Med Future Inc·Product code MTV·August 15, 2002
One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips
FDA Recall
Terminated
·Core Care Technologies, Inc·Product code NBW·October 14, 2006
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
FDA Recall
Terminated
·Lockheed Martin Gyrocam Systems, Inc.·Product code REX·January 21, 2010
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
FDA Recall
Terminated
·Ultroid Technologies, Inc.·Product code KNS·October 19, 2016
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
FDA Recall
Terminated
·Ultroid Technologies, Inc.·Product code KNS·October 19, 2016
Ultroid Sterile Disposable Probes sold individually
FDA Recall
Terminated
·Ultroid Technologies, Inc.·Product code KNS·October 19, 2016
***REF #250***TAPSCOPE 550F. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series female connector thermistor. LOT xxxxxxx 400095-0250-C 100902. www.cardiocommand.com. ***REF #250-0010***TAPSCOPE 550F CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400156-B 091101. ***REF #250-0025***TAPSCOPE 550F Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistor. FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: CARDIOCOMMAND, INC.Tampa, FL USA 33607. (800) 231-6370(813) 289-5555. www.cardiocommand.com. 400216-A 100902.
FDA Recall
Terminated
·Cardiocommand Inc.·Product code LPA·October 25, 2010
***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.cardiocommand.com. ***REF #200-0010***TAPSCOPE 550 CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400155-B 091101. ***REF #200-0025***TAPSCOPE 550 Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. ***LOT xxxxxxx***FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: Tampa, FL USA 33607. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. 400215-A 100902.
FDA Recall
Terminated
·Cardiocommand Inc.·Product code LPA·October 25, 2010
Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device. Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004-0011
FDA Recall
Terminated
·Datascope Corporation·Product code GEI·May 7, 2007
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
FDA Recall
Terminated
·Ultroid Technologies, Inc.·Product code KNS·October 19, 2016
Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits). Label located on the back of the WPU. Product is labeled in part: "***Invivo Corporation 12601 Research Parkway, Orlando, FL 32826***Made in U.S.A.***REF 3160***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Label located on the bottom of the DCU. Product is labeled in part: ***Invivo Corporation 12601 Research Parkway Orlando, FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Display Controller Unit (DCU) is labeled in part: "***Invivo***PRECESS***". Wireless Processing Unit (WPU) is labeled in part: "***Invivo***". NOTE: WPU AND DCU MAY HAVE THE SAME OR DIFFERENT SERIAL NUMBERS. The radio is responsible for wireless communication between the Wireless Processing Unit and the Display Controller Unit. Precess is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·September 23, 2011