378 results
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52ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·September 4, 2024
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT12060; e) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT14705; f) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT17190; g) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT17195; h) CENTURION MEDICAL PRODUCTS LACERATION TRAY (P/S), Reorder Number SUT17755; i) CENTURION MEDICAL PRODUCTS LACERATION TRAY (P/S), Reorder Number SUT18475; j) CENTURION MEDICAL PRODUCTS SUTURE SET, Reorder Number SUT19505; k) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT19620; l) CENTURION MEDICAL PRODUCTS UNITYPOINT HEALTH LACERATION T, Reorder Number SUT20205; m) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT20410; n) CENTURION MEDICAL PRODUCTS BASIC SUTURE TRAY, Reorder Number SUT21360; o) CENTURION MEDICAL PRODUCTS SUTURE PACK TRAY, Reorder Number SUT4655; p) CENTURION MEDICAL PRODUCTS SUTURING SET, Reorder Number SUT5765; q) CENTURION MEDICAL PRODUCTS UMBILICAL CATH INSERT TRAY, NO, Reorder Number UVT1075A; r) CENTURION MEDICAL PRODUCTS UMBILICAL VESSEL CATH INSERT T, Reorder Number UVT505; s) CENTURION MEDICAL PRODUCTS UMBILICAL VESSEL TRAY, Reorder Number UVT835;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRP·December 7, 2022
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150; e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155; f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215; g) STERILE 5-1/2" S/S SCISSOR (SS507), Product Code 66260; h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350; i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365; j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450; k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465; l) STERILE CURV MAYO SCISSOR 5 1/2" (81310), Product Code 66665; m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710; n) STERILE 6 1/2" S/B SCISSOR (11109SB), Product Code 66820; o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845; p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885; q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890; r) STERILE CURVED METZENBAUM (ST142), Product Code 66895; s) STERILE B/B SCISSOR 6 1/2", Product Code 66995; t) STERILE 6 3/4" MAYO SCISSOR, Product Code 67160; u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165; v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185; w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450; x) STERILE 51/2" EPISIOTOMY SCISSOR (11140), Product Code 67645; y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650; z) STERILE REPROCESSED 6 1/2" S/B SCISSOR, Product Code 66820K; aa) ST METZENBAUM SCISSOR CURVED 9"(MBS90C), Product Code I68510; bb) ST UMBILICAL SCISSOR, CRVD, 4" (11148), Product Code I68575; cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790; dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600; ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K; ff) STERILE STR MAYO SCISSOR 5 1/2" (ST115), Product Code TRI67630 MEDLINE: MEDLINE manual surgical kits labeled as: a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000; b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRW·February 23, 2024
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573
FDA Recall
Open, Classified
·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FON·February 19, 2024
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 21, 2025
Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System
FDA Recall
Open, Classified
·GE Healthcare·Product code LLZ·March 28, 2023
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar
FDA Recall
Open, Classified
·Medicrea International Vancia Vancia Rillieux La Pape France·Product code MAX·July 12, 2023
IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical
FDA Recall
Open, Classified
·Medicrea International Vancia Vancia Rillieux La Pape France·Product code ODP·July 12, 2023
GRANVIA-C, REF numbers: a) A13111427, b) A13112567, c) A13113456, d) A13131516, e) A13131789, f) A13132012, g) B13111014, h) B13111015, i) B13111016, j) B13111017, k) B13111025, l) B13111026, m) B13111027, n) B13111034, o) B13111035, p) B13111036; intervertebral fusion device - cervical
FDA Recall
Open, Classified
·Medicrea International Vancia Vancia Rillieux La Pape France·Product code MJO·July 12, 2023
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
FDA Recall
Open, Classified
·Medicrea International Vancia Vancia Rillieux La Pape France·Product code MAX·July 12, 2023
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar
FDA Recall
Open, Classified
·Medicrea International Vancia Vancia Rillieux La Pape France·Product code ODP·July 12, 2023
PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
FDA Recall
Open, Classified
·Medicrea International Vancia Vancia Rillieux La Pape France·Product code MNI·July 12, 2023