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Sources: EU EUDAMED, US FDA
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FDA Recall
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OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
FDA Recall
Terminated
·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
FDA Recall
Terminated
·LivaNova USA Inc·Product code LYJ·November 16, 2018
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
FDA Recall
Terminated
·LivaNova USA Inc·Product code LYJ·November 16, 2018
The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
FDA Recall
Terminated
·Fresenius Kabi, LLC·Product code LKN·April 19, 2011
WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies
FDA Recall
Terminated
·Bigwall Enterprises·Product code KFZ·November 20, 2015
Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systems, Distributed by : Weck Closure Systems, One Weck Dr. Research Triangle Park, NC 27709, USA
FDA Recall
Terminated
·Product code FFZ·January 25, 2001
Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.
FDA Recall
Terminated
·Medical Indicators, Inc.·Product code FQZ·July 10, 2013
VAPORIZER VICKS 1.5GAL Item Number: 2354942
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code KFZ·March 16, 2021
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
FDA Recall
Terminated
·BearCare, Inc.·Product code FQZ·May 10, 2023
Vicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief of Cold and Flu Symptoms'' sold over the counter. Firm on the label: Distributed by Kaz Inc., under license from the Procter & Gamble Company, Cincinnati, OH 45202. UPC code 3 28785 20610 4.
FDA Recall
Terminated
·Product code KFZ·April 15, 2003
MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
FDA Recall
Terminated
·Hemostatix Medical Technologies LLC·Product code GEI·July 27, 2010
HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF 7013-5050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
FDA Recall
Terminated
·Hemostatix Medical Technologies LLC·Product code GEI·July 27, 2010
Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l. U H S NEURO PACK SC m. NEURO PACK-CELEBRATION n. NEURO PACK o. NEURO BASIN PACK-LF p. NEURO PACK q. MAJOR NEURO PK-LF r. NINOR NEURO PK-LF s. NEURO VP SHUNT/VAGAL NERVE-RF t. NEURO PACK-LF u. NEURO PACK v. CRANIOTOMY w. PEDIATRIC NEURO PACK x. NEURO MATRIX PACK y. ACOUSTIC NEUROMA PACK-LF z. MAJOR NEURO PACK-LF aa. SCRIPPS SW NEURO PACK-LF bb. NEURO PACK cc. GENERAL PACK dd. NEURO PK ee. NEURO PACK ff. NEURO PACK gg. NEURO PACK hh. NEURO PACK-LF ii. NEURO PACK jj. NEURO PACK kk. NEURO PACK ll. NEURO PACK mm. CRANIOTOMY PACK nn. PK, NEURO-MINOR oo. NEURO PACK pp. NEURO PACK qq. NEURO PACK rr. PK, NEURO-MINOR ss. NEURO BASIC tt. NEURO BASIC uu. CRANIOTOMY PACK (CRSJE)227-LF vv. NEURO PACK ww. NEURO PACK xx. NEURO CRANI PACK yy. NEURO PACK zz. NEURO TRAY-LF aaa. NEURO PACK bbb. WH NEURO PACK ccc. RFT ISC-N NEURO PACK ddd. NEURO-LF eee. NEURO PACK fff. NEURO LUMBAR PACK ggg. NEURO FUSION PACK-LF hhh. NEURO CERVICAL PACK iii. NEURO PACK jjj. VP SHUNT PACK kkk. NEURO BASIC PACK lll. NEURO PACK mmm. CHRISTUS CHILDRENS NEURO PK nnn. CHRISTUS CHILDRENS VP SHUNT PK ooo. RF NEURO-SHUNT PACK ppp. NEURO PACK qqq. NEURO PACK rrr. NEURO ST DAVIDS MEDICAL CTR sss. GIO NEURO PACK ttt. NEURO KIT uuu. DISCECTOMY PACK vvv. NEURO PACK www. BASIC NEURO PACK-LF xxx. NEURO PACK yyy. NEURO PACK zzz. NEURO aaaa. NEURO bbbb. FHCW NEURO PACK cccc. NEURO FERREE dddd. NEURO eeee. NEURO PACK CW ffff. NEURO gggg. FHT NEURO hhhh. NEURO BASIC iiii. NEURO LUMBAR jjjj. NCH NEURO kkkk. TAVI llll. CHN OR NEURO mmmm. NEURO PACK-LF nnnn. NEURO-CRANI-LF
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OJG·November 17, 2022
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN LAPAROSCOPY CDS-LF m. GYN LAPAROSCOPY CDS UCC-LF n. DAY SURG GYN LAP CDS o. GYN LAPAROSCOPY CDS p. DAVINCI HYSTERECTOMY CDS q. GYN LAP/ROBOTIC r. DAVINCI PACK-LF s. DAVINCI PACK-LF t. GYN LAPAROSCOPY PACK-LF u. ROBOTIC PACK v. GYN LAP - UNIV w. BASIC LAVH PACK x. GYN/LAPAROSCOPY PACK-LF y. LAPAROSCOPIC GYN PACK-LF z. DAVINCI PACK-LF aa. SCC GYN LAPAROSCOPY PACK bb. URO GYN PACK-LF cc. GYN LAPAROSCOPY PACK dd. TUBAL PACK ee. GYN LAP PACK-LF ff. LAVH PACK gg. GYN LAPAROSCOPY-LF hh. LAVH PACK ii. PK-GYN-LAPAROSCOPY jj. MAJOR LAP PACK 2-LF kk. TUBAL PACK ll. GYN LAPAROSCOPY PACK-LF mm. PK, ROBOTICS-GYN nn. SVMMC GEN ROBOTIC PACK oo. SVMMC GYN ROBOTIC PACK pp. PACK, GYN-D&C qq. DA VINCI PROSTATE/COLPOPEXY rr. ROBOT PACK ss. PK, GYN-LAPAROSCOPY tt. LAPAROSCOPIC GYN PACK uu. DAVINCI PACK-RFD vv. GYN ROBOTIC PACK ww. LAVH PACK xx. ST. ANNE'S MULTI PORT PACK yy. LAVH PACK zz. SOUTH SC RFT GYN LAP PACK aaa. GYN LAPAROSCOPY PACK bbb. LITHOTOMY PENILE PACK ccc. DAVINCI GENERAL PACK ddd. DAVINCI GYN PACK eee. DAVINCI GYN PACK fff. ROBOTIC PROSTATE PACK ggg. GYN ROBOTIC PACK-LF hhh. SCRIPPS SW ROBOTIC PACK iii. GYN LITHOTOMY PACK jjj. GYN LAPAROSCOPY PACK kkk. DEACONESS PELVIC LAP PACK lll. WOMENS ROBOT PACK mmm. GYN LAPAROSCOPY PACK-LF nnn. MAJOR GYN PACK ooo. GYN LAPAROSCOPY PACK ppp. TUBAL PACK-LF qqq. PK, GYN-LAPAROSCOPY rrr. LAVH PACK sss. LAPAROTOMY PACK ttt. URO/GEN ROBOTIC PACK uuu. BASIC ROBOTIC PACK vvv. LAPAROSCOPIC GYN PACK www. PK, ROBOTICS-GYN xxx. PQ CHG CTRY GYN LAP PK yyy. GYN DAVINCI PACK zzz. ROBOT GYN SHARED aaaa. PK, ROBOTICS-GEN bbbb. DAVINCI PACK cccc. ROBOTIC GYN PACK dddd. ROBOTICS PACK eeee. PK- ROBOTICS ffff. GYN LAPAROSCOPY gggg. GU ROBOTIC PACK hhhh. GYN PACK iiii. BASIC GYN PACK jjjj. BWH GYN ROBOTICS PACK kkkk. BWH GU ROBOTICS PACK llll. URO GYN PACK mmmm. GYN LAP PACK nnnn. GYN LAPAROSCOPY oooo. ROBOTIC pppp. GYN ROBOTIC qqqq. CV ROBOTIC SET UP rrrr. GYN LAPAROSCOPY ssss. ROBOTIC LAVH tttt. ROBOTIC LAP CHOLE uuuu. GYN LAPAROSCOPY vvvv. GYN LAPAROSCOPY wwww. GYN ROBOTIC xxxx. GYN ENDOSCOPY-LF yyyy. GYN LAPAROSCOPY zzzz. LAP ROBOTIC aaaaa. TUBAL LIGATION CDS bbbbb. GYN LAPAROSCOPY ccccc. ROBOTIC GYN & GU ddddd. ROBOTIC eeeee. GYN LAPAROSCOPY fffff. ROBOT GYN ggggg. GYN LAPAROSCOPY hhhhh. FHWC ROBOTIC iiiii. GYN LAPAROSCOPY jjjjj. GYN LAPAROSCOPY kkkkk. ROBOTIC lllll. PELVISCOPY mmmmm. GENERAL ROBOT-TCN nnnnn. ROBOTICS ooooo. CVOR ROBOT ppppp. GU-GEN ROBOTIC qqqqq. FLOYD LAP GYN rrrrr. GYN ROBOTIC sssss. GYN LAPAROSCOPY CDS ttttt. LAP TUBAL uuuuu. DAVINCI GENERAL vvvvv. DAVINCI LOW ANTERIOR RESECTION wwwww. GYN xxxxx. PELVISCOPY PACK yyyyy. GYN LAPAROSCOPY STD PACK-LF zzzzz. LAP GYN PACK-LF
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OHD·November 17, 2022
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o. OPEN HEART CDS p. MEMORIAL MED CTR BYPASS q. OPEN HEART PEDS r. OPEN HEART CDS-4 s. OPEN HEART t. CAB CDS u. VASCULAR CDS v. VALVE CDS w. OPEN HEART PACK-LF x. VASCULAR CDS-LF y. OPEN HEART B CDS-LF z. CRANIOTOMY CDS aa. OPEN UROLOGY CDS-LF bb. TOTAL KNEE CDS cc. LOWER EXTREMITY CDS-LF dd. LAMINECTOMY CDS ee. ENDOVASCULAR CDS ff. VASCULAR gg. VASCULAR CDS-3 hh. VASCULAR ACCESS CDS ii. ZALE PUMP CDS jj. CUH ENDOVASCULAR CDS kk. CUH MINOR VASCULAR CDS ll. FHT CVOR CABG mm. OPEN HEART CDS nn. OPEN HEART CDS oo. CAROTID ENDARTERECTOMY CDS-LF pp. PACER CDS qq. PERIPHERAL VASCULAR CDS rr. ACH OPEN HEART ss. ACH OPEN HEART tt. OPEN HEART CDS uu. VASCULAR CDS vv. CV CDS ww. OPEN HEART CABG PACK-LF xx. MAJOR VASCULAR PACK-LF yy. CARDIOVASCULAR PACK-LF zz. VASCULAR HARPER PACK-LF aaa. CABG 1 OR 2 HARPER PACK bbb. TAVR 1 PACK-LF ccc. ENDO VASCULAR PACK-LF ddd. OPEN HEART A & B PACK eee. PACEMAKER IMPLANT PACK-LF fff. PERIPHERAL VASCULAR PACK-LF ggg. PACEMAKER PACK-LF hhh. RR-NEURO VASCULAR PACK-LF iii. CARDIAC CHEST PACK 80701 jjj. OPEN HEART PACK-LF kkk. PACEMAKER PACK-LF lll. CARDIOVASCULAR PACK-LF mmm. OPEN HEART PACK A & B nnn. MINOR VASCULAR PACK ooo. OPEN HEART PACK-LF ppp. SMALL VASCULAR PACK-LF qqq. MAJOR VASCULAR PACK-LF rrr. PEDIATRIC CARDIAC PACK-LF sss. OH VALVE PACK-LF ttt. HEART OVERHEAD TABLE PACK uuu. OPEN HEART PACK vvv. PACEMAKER PACK-LF www. VASCULAR PACK-LF xxx. OPEN HEART PACK yyy. VASCULAR PACK zzz. CV BASIC SET UP PACK aaaa. UNIVERSAL OPEN HEART PACK bbbb. VASCULAR BYPASS PACK-LF cccc. BMC CABG PACK A dddd. CUSTOM CAROTID eeee. A-V FISTULA PACK-LF ffff. PERIPHERAL VASCULAR PACK-LF gggg. ECMO PACK hhhh. HEART PACK iiii. CABG PACK A&B jjjj. OPEN HEART PACK kkkk. CV A & B llll. PEDIATRIC OPEN HEART-NS-LF mmmm. PACEMAKER NORTH nnnn. OPEN HEART PACK oooo. SVMMC CORE OPEN HEART PACK-LF pppp. PACEMAKER TRAY-LF qqqq. PACEMAKER PACK rrrr. MAJOR VASCULAR-RF-LF ssss. AV FISTULA-LF tttt. PACEMAKER PACK uuuu. VASCULAR PACK vvvv. PACEMAKER wwww. MAJOR VASCULAR PACK xxxx. MAJOR VASCULAR PACK yyyy. VASCULAR PACK zzzz. PACEMAKER PACK-LF aaaaa. RRMC CABG AUXILIARY TRAY bbbbb. RRMC OPEN HEART PACK ccccc. MAJOR VASCULAR PACK ddddd. PACEMAKER PACK eeeee. PACEMAKER TRAY fffff. PACEMAKER PACK ggggg. PACEMAKER PACK hhhhh. AV FISTULA PK-LF iiiii. FHT PACER PACK jjjjj. PACEMAKER SET UP PACK kkkkk. MAJOR VASCULAR PACK lllll. PACEMAKER PACK-LF mmmmm. CAROTID PACK nnnnn. MAJOR VASCULAR PACK ooooo. VASCULAR PACK GH-LF ppppp. A-V FISTULA PACK GH-LF qqqqq. VASCULAR PACK MH-LF rrrrr. PACEMAKER PACK L J sssss. OPEN HEART ttttt. OPEN HEART SUPPLY TRAY uuuuu. PACEMAKER PACK vvvvv. PACEMAKER PACK wwwww. VASCULAR PACK xxxxx. BASIC OPEN HEART PACK A B yyyyy. VASCULAR PACK zzzzz. OPEN HEART TRAY A-LF aaaaaa. VASCULAR PACK bbbbbb. PACEMAKER PACK cccccc. OPEN HEART PACK dddddd. ENDOVASCULAR PACK-LF eeeeee. VASCULAR PACK-LF ffffff. BASIC OPEN HEART PACK-LF gggggg. OPEN VASCULAR PACK-LF hhhhhh. PK, EP LAB PACEMAKER iiiiii. PK, OPEN HEART-CABG jjjjjj. OPEN HEART PACK kkkkkk. PK, OPEN HEART- A&B llllll. SVMMC VASCULAR MAJOR PACK mmmmmm. CV PACK nnnnnn. OPEN HEART PACK A AND B oooooo. SVMMC CAROTID PACK pppppp. PK, OPEN HEART-CABG A&B qqqqqq. PK, OPEN HEART-A&B rrrrrr. VASCULAR PACK ssssss. PK, OPEN HEART tttttt. PK, OPEN HEART uuuuuu. OPEN HEART PACK vvvvvv. PK, OPEN HEART-A&B wwwwww. OPEN HEART PACK xxxxxx. PK, OPEN HEART-CABG yyyyyy. PK, OPEN HEART zzzzzz. CASTRO CABG-COMPONENT PACK aaaaaaa. RE-ENTRY PACK bbbbbbb. HEART PACK ccccccc. OPEN HEART SUPPLY PACK ddddddd. PK, OPEN HEART-CABG eeeeeee. CABG PROCEDURE PACK fffffff. CABG PACK ggggggg. PK, OPEN HEART hhhhhhh. VASCULAR GRAFT PACK iiiiiii. PK, OPEN HEART jjjjjjj. VASCULAR PACK kkkkkkk. PK,
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·November 17, 2022