5,618 results
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15ms
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Sources: EU EUDAMED, US FDA
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
FDA Recall
Open, Classified
·Product code CAH·October 10, 2025
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZATION KIT/AK-05503; EPIDURAL CATHETERIZATION KIT/AK-05503-L; SPINAL ANES/EPIDURAL CATH KIT/AK-05560; SPINAL ANES/EPIDURAL CATH KIT/ASK-02520-SBMC1; EPIDURAL CATHETERIZATION KIT/ASK-05400-BW1; EPIDURAL CATHETERIZATION KIT/ASK-05400-GH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05401-LMC; EPIDURAL CATHETERIZATION KIT/ASK-05401-NM; SPINAL ANES/EPIDURAL CATH KIT/ASK-05500-BID1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-JHH1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-MCV1; EPIDURAL CATHETER KIT: 19GA X 90CM ASK-05500-MVH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-UMC; 19 GA X 35.5 IN EPIDURAL CATHETER KIT/ASK-05502-MLH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-JMH1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-MKD2; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-OM1; EPIDURAL CATHETERIZATION KIT/ASK-17019-SM; EPIDURAL CATHETERIZATION KIT/BP-05501; EPIDURAL CATHETERIZATION KIT/CK-05401; EPIDURAL CATHETERIZATION KIT/HS-05501; EPIDURAL CATHETERIZATION KIT/MM-05501; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TK; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKD; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKL; EPIDURAL CATHETERIZATION KIT/MSO-05401-JMH; EPIDURAL CATHETERIZATION KIT/NM-05401; EPIDURAL CATHETERIZATION KIT/SJ-05501; EPIDURAL CATHETERIZATION KIT/SM-05401; EPIDURAL CATHETER KIT: 19 GA X 90 CM/TM-05401; EPIDURAL CATHETERIZATION KIT/TM-05502; SPINAL ANES/EPIDURAL CATH KIT/UI-05502; SPINAL ANES/EPIDURAL CATH KIT: 19 GA/ASK-05400-SHM; EPIDURAL CATH KIT: 19 GA/ASK-05400-UOM; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-MR; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-TM; EPIDURAL CATHETERIZATION KIT/ASK-05501-BHL1; EPIDURAL CATHETERIZATION KIT/ASK-05501-GH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-SM; EPIDURAL CATHETERIZATION KIT/ASK-05502-BSM; EPIDURAL CATHETERIZATION KIT/ASK-05502-MGH1; EPIDURAL CATHETERIZATION KIT/ASK-05503-BWB1; EPIDURAL CATHETERIZATION KIT/ASK-05503-HMH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-SPH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-UPM1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-UCI2; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-17019-UMP; EPIDURAL CATHETERIZATION KIT/MH-05503-1; EPIDURAL CATHETERIZATION KIT/ASK-05401-VB2; Epidural Catheterization Kit: 19GA/ASK-05500-SC1; Epidural Catheterization Kit: 19GA/ASK-05500-SC3; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-AFH1; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-BMC; EPIDURAL CATHETERIZATION KIT/ASK-05502-NY; EPIDURAL CATHETERIZATION KIT/ASK-17019-RMH
FDA Recall
Open, Classified
·ARROW INTERNATIONAL, LLC·Product code BSO·April 21, 2026
Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OKG·June 27, 2024
Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CAH·April 8, 2024
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks: Product name (build number) UDI-DI RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·December 30, 2021
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10775; ANESTHESIA CIRC ADULT 120-LF DYNJAA10601; ANESTHESIA CIRCUIT - LF DYNJAA10261B; ANESTHESIA CIRCUIT 120EXP-LF DYNJAA10741A; ANESTHESIA CIRCUIT ADULT-LF DYNJAA0380A DYNJAA10641 DYNJAA10706B DYNJAA10851 DYNJAA10922B DYNJAA10971A DYNJAA11030A DYNJAA11087 DYNJAA11126; ANESTHESIA CIRCUIT-LF DYNJAA0309A DYNJAA0368A DYNJAA10368A DYNJAA10392 DYNJAA10430A DYNJAA10547A DYNJAA10639A DYNJAA10656A DYNJAA10685A DYNJAA10685B; CIRC 120" EXP 1 BV HMEF 3L GSL DYNJAA10920; EXPANDABLE CIRCUIT-LF DYNJAA11095; NM ANESTHESIA TURNOVER KIT DYNJAA0433; PROV HEALTH HEPA CIRC #2-LF DYNJAA0360; SPTMPX01IA CIRCUIT ADULT-LF DYNJAA10973A;
FDA Recall
Open, Classified
·Product code CAI·October 10, 2025
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.
FDA Recall
Open, Classified
·Trividia Health, Inc.·Product code NBW·February 6, 2026
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. ANES SET W/DUAL FEM.LL SAFEPORT MANIFOLD; Catalog Number: 456520.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FPA·October 29, 2025
Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number DYNDA1598C; 6) INTUBATION KIT , Pack Number DYNDA1598CH ; 7) ANESTHESIA KIT , Pack Number DYNDA2958; 8) ANESTHESIA PREP CUSTOM TRAY, Pack Number DYNDH1758; 9) ADULT LUMBAR PUNCTURE TRAY , Pack Number DYNDH1889; 10) PEDIATRIC CARDIAC PACK-LF, Pack Number DYNJ0537013Y; 11) PEDIATRIC MINOR PK, Pack Number DYNJ49035B; 12) WMC PEDIATRIC ADD ON PACK-LF, Pack Number DYNJ50644; 13) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283B; 14) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283C; 15) AIRWAY PACK , Pack Number DYNJ60239B; 16) ANESTHESIA PAIN PK LEAGUE, Pack Number DYNJ67925; 17) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603I ; 18) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603J ; 19) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503A ; 20) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503B ; 21) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503C ; 22) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503D ; 23) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503F ; 24) #######, Pack Number DYNJ905503F ; 25) MZ MDL AIRWAY, Pack Number DYNJ910129; 26) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA10379 ; 27) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA6572; 28) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 29) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 30) REGIONAL ANESTHESIA PREP TRAY , Pack Number DYNJRA0376A ; 31) ANESTHESIA KIT , Pack Number DYNJRA0424A ; 32) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767; 33) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767A ; 34) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767B ; 35) ANESTHESIA SUPPORT TRAY , Pack Number DYNJRA0779A ; 36) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0887A ; 37) ANESTHESIA TRAY, Pack Number DYNJRA0909; 38) SPINAL ANESTHESIA TRAY/WHITE, Pack Number DYNJRA0955A ; 39) #####, Pack Number DYNJRA0955A ; 40) ANESTHESIA SUPPORT TRAY/B, Pack Number DYNJRA0968; 41) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119; 42) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119A ; 43) ANESTHESIA TRAY, Pack Number DYNJRA1355; 44) ANESTHESIA TRAY, Pack Number DYNJRA1355A ; 45) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1577A ; 46) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659; 47) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659A ; 48) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1757; 49) ANESTHESIA PREP KIT, Pack Number DYNJRA1899; 50) ANESTHESIA TRAY, Pack Number DYNJRA1934; 51) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA2087; 52) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA2151; 53) PRE OP ANES KIT, Pack Number DYNJRA2228; 54) PRE OP ANES KIT, Pack Number DYNJRA2228H; 55) CUSTOM ANESTHESIA KIT-LF, Pack Number GSP478I; 56) REGIONAL TRAY, Pack Number PAIN0385B; 57) EPIDURAL ANESTHESIA KIT , Pack Number PAIN1982 ; 58) CIRC PACK-LF, Pack Number PHS41720I; 59) CIRC PACK-LF, Pack Number PHS41720J; 60) ANES CIRC 90 EXP, Pack Number VM96DLEX2L
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CAI·April 8, 2024
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK
FDA Recall
Open, Classified
·Trividia Health, Inc.·Product code NBW·February 6, 2026
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. ANESTHESIA SET W/ SAFEPORT MANIFOLD; Catalog Number: 456521. 2. ANES SET W/TRIPLE LL SAFEPORT MANIFOLD; Catalog Number: 456522.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FPA·October 29, 2025
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 14, 2023
IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
FDA Recall
Open, Classified
·Philips Electronics North America Corporation·Product code DSI·October 10, 2018
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024