44 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
FDA Recall
Open, Classified
·ETHICON, INC. Calle Durango 2751 Col. Parque Industrial Americas, Juarez Juarez Mexico·Product code GAN·October 8, 2024
EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code DNN·March 27, 2008
EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5
FDA Recall
Terminated
·Hospira, Inc.·Product code DNN·July 26, 2010
Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code GBN·October 8, 2014
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
FDA Recall
Open, Classified
·Ethicon, Inc.·Product code GAN·May 10, 2024
Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
FDA Recall
Terminated
·Gen-Probe Inc·Product code MDK·May 2, 2007
Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.
FDA Recall
Terminated
·Gen-Probe Inc·Product code LQF·December 30, 2008
Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.
FDA Recall
Terminated
·Gen-Probe Inc·Product code MDK·December 30, 2008
Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.
FDA Recall
Terminated
·Gen-Probe Inc·Product code LQF·December 30, 2008
Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
FDA Recall
Terminated
·Gen Probe Inc·Product code NDZ·June 11, 2004
APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.
FDA Recall
Terminated
·Gen-Probe Inc·Product code OIE·April 17, 2014
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TOTAL KNEE CDS-LF n. TOTAL SHOULDER CDS-LF o. TOTAL KNEE CDS-3 p. TOTAL HIP CDS-3 q. LOWER EXTREMITY CDS-LF r. TOTAL HIP-LF s. TOTAL HIP/KNEE CDS t. SPINE PROCEDURE u. OPEN HEART v. LAMI w. UPPER EXTREMITY CDS x. LOWER EXTREMITY CDS y. KNEE ARTHROSCOPY CDS z. KNEE ARTHROSCOPY CDS-LF aa. SHOULDER CDS-LF bb. PODIATRY CDS cc. KNEE ARTHROSCOPY CDS dd. SHOULDER ARTHROSCOPY CDS ee. ACL CDS ff. CRANIOTOMY CDS gg. TOTAL KNEE CDS hh. TOTAL KNEE ii. TOTAL HIP CDS jj. NEW LONDON TOTAL KNEE CDS kk. TRAUMA CDS-LF ll. TOTAL JOINT CDS mm. CRANIOTOMY CDS-1 nn. SHOULDER CDS-1 oo. SPINE CDS-1 pp. TOTAL KNEE CDS-1 qq. TOTAL HIP CDS-1 rr. LOWER EXTREMITY CDS-2 ss. HAND CDS-2 tt. KNEE ARTHROSCOPY CDS-2 uu. HAND CDS vv. BACK CDS ww. FRACTURE TABLE CDS xx. ORTHO OP CDS yy. ARTHROSCOPY CDS zz. ORTHO MINOR CDS aaa. TOTAL JOINT KNEE CDS bbb. TOTAL JOINT HIP CDS ccc. SHOULDER CDS-LF ddd. ZALE CRANIOTOMY CDS eee. ZALE TOTAL KNEE CDS fff. ZALE EXTREMITY CDS ggg. OPEN SHOULDER CDS hhh. LOWER EXTREMITY CDS iii. FHT TOTAL HIP jjj. FHT TOTAL KNEE RPLCMNT kkk. TOTAL HIP CDS lll. TOTAL KNEE CDS mmm. CCOC ACL-LF nnn. CCOC SPINAL FUSION ooo. CCOC MAJOR EXTREMITY ppp. EXTREMITY CDS qqq. PODIATRY CDS rrr. SHOULDER CDS sss. DISTAL LEG CDS ttt. HIP NAILING CDS uuu. SHOULDER CDS vvv. TOTAL HIP CDS www. UPPER EXTREMITY CDS xxx. BASIC ORTHO CDS yyy. TOTAL HIP PROCEDURE zzz. TOTAL JOINT CDS-LF aaaa. SHOULDER CDS-LF bbbb. HAND CDS-LF cccc. KNEE ARTHROSCOPY CDS-LF dddd. TOTAL JOINT eeee. UPPER EXTREMITY CDS ffff. LOWER EXTREMITY CDS gggg. GENERAL ORTHO CDS hhhh. ARTHROSCOPY CDS iiii. KNEE ARTHROSCOPY CDS jjjj. SHOULDER ARTHROSCOPY CDS kkkk. KNEE ARTHROSCOPY CDS llll. TOTAL ORTHO CDS mmmm. GROTH LOWER EXTREMITY CDS nnnn. HIP TOTAL PACK-ANTERIOR oooo. PRAIRIE STAR SPINE CDS pppp. 4TH FLOOR SHOULDER ARTHROSCOPY qqqq. FOOT & ANKLE CDS-LF rrrr. LAMI MICRODISC-LF ssss. HIP PINNING CDS-LF tttt. KNEE ARTHROSCOPY CDS-LF uuuu. UPPER EXTREMITY CDS-LF vvvv. SPINE CDS-LF wwww. SPINE CDS-LF xxxx. LOWER EXTREMITY/ELBOW CDS yyyy. HAND CDS zzzz. KNEE ARTHROSCOPY CDS aaaaa. SPINE CDS bbbbb. TOTAL HIP CDS ccccc. KNEE ARTHROSCOPY CDS ddddd. HAND CDS eeeee. TOTAL KNEE CDS-LF fffff. SPINE MODULE CDS ggggg. UPPER EXTREMITY CDS-LF hhhhh. TOTAL JOINT CDS iiiii. TOTAL JOINT CDS jjjjj. ORTHO TRAUMA CDS kkkkk. ACF CDS lllll. CRANIOTOMY CDS mmmmm. TOTAL JOINT CDS nnnnn. ARTHROSCOPY CDS ooooo. EXTREMITY CDS ppppp. PODIATRY CDS qqqqq. LAMINECTOMY CDS rrrrr. EXTREMITY CDS sssss. TOTAL KNEE CDS ttttt. TOTAL HIP CDS uuuuu. TOTAL KNEE vvvvv. ANTERIOR HIP wwwww. HAND WRIST FOREARM xxxxx. LOWER EXTREMITY yyyyy. TOTAL HIP zzzzz. TOTAL KNEE aaaaaa. SHOULDER ARTHROSCOPY bbbbbb. SHOULDER ARTHROSCOPY PK cccccc. LUMBAR LAMINECTOMY PACK dddddd. CRANIOTOMY PACK-LF eeeeee. OPEN SHOULDER PACK-LF ffffff. TOTAL HIP PACK-LF gggggg. TOTAL KNEE PACK-LF hhhhhh. SHOULDER ARTHROSCOPY PACK-LF iiiiii. EXTREMITY PACK jjjjjj. CLOSED HEART PEDS PACK kkkkkk. ORTHO MINOR PACK-LF llllll. FRACTURE TABLE PACK-LF mmmmmm. HAND - EDOC PACK-LF nnnnnn. FOOT LV - EDOC PACK-LF oooooo. SHOULDER - EDOC PACK-LF pppppp. FOOT ANKLE PACK-LF qqqqqq. OPEN HEART TRAY rrrrrr. SHOULDER PACK-LF ssssss. ROCKVILLE ASC EXTREMITY PACK tttttt. NEURO SPINE DRH PACK-LF uuuuuu. DRH ORTHOPEDIC I AND D PACK-LF vvvvvv. KNEE ARTHROSCOPY MIOSH PACK-LF wwwwww. HAND AND FOOT PACK-LF xxxxxx. SPINE BUNDLE PACK yyyyyy. MINOR ORTHOPEDIC PACK-LF zzzzzz. FEM POP PACK-LF aaaaaaa. LAMINECTOMY PACK-LF bbbbbbb. CRANIOTOMY PACK-LF ccccccc. MAJOR ORTHO PACK-LF ddddddd. HAND WRIST PACK-LF eeeeeee. TOSH PODIATRY PACK-LF fffffff. TOTAL HIP ARTHROPLASTY PACK-LF ggggggg. TOSH UPPER EXTREM MIOSH PK-LF hhhhhhh. OPEN HEART CHILDRENS PACK-LF iiiiiii. CRANIOTOMY PACK-LF jjjjjjj. SPINE HARPER PACK-LF kkkkkkk. CRANIOTOMY
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OJH·November 17, 2022
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
FDA Recall
Terminated
·LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel·Product code NBW·August 29, 2019
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025