26 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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BostonSight SCLERAL Lens
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
BostonSight PROSE Lens.
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack Number DYNDH1113; 6) ARTHROGRAM TRAY, Pack Number DYNDH1134; 7) BIOPSY TRAY, Pack Number DYNDH1137C; 8) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 9) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 10) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1275; 11) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 12) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 13) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321; 15) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324B; 16) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 17) LUMBAR TRAY, Pack Number DYNDH1500; 18) TRAY SAFETY LUMBAR PUNCTURE 18GX3.5, Pack Number DYNDH1538; 19) TRAY SAFETY LUMBAR PUNCTURE 20GX3.5, Pack Number DYNDH1539; 20) LUMBAR TRAY, Pack Number DYNDH1540; 21) LUMBAR TRAY, Pack Number DYNDH1540A; 22) BIOPSY PACK, Pack Number DYNDH1556B; 23) BIOPSY KIT, Pack Number DYNDH1570; 24) MYELOGRAM TRAY, Pack Number DYNDH1574; 25) BIOPSY BASIC PACK, Pack Number DYNDH1588; 26) BIOPSY TRAY, Pack Number DYNDH1693; 27) BIOPSY TRAY, Pack Number DYNDH1693A; 28) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1698; 29) BIOPSY PACK, Pack Number DYNDL1462B; 30) LACERATION TRAY, Pack Number DYNDL1774A; 31) LACERATION TRAY, Pack Number DYNDL1887; 32) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 33) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B; 34) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 35) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 36) MYELOGRAM TRAY W/WATER SOLUBLE, Pack Number DYNJTS04035; 37) LUMBAR TRAY, Pack Number DYNJTS0422; 38) MYELOGRAM TRAY, Pack Number DYNJTS0514; 39) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS07025; 40) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 41) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4302; 42) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 43) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 44) CENTRAL LINE INSERTION KIT W/16CM CATH, Pack Number ECVC7440A; 45) OB DELIVERY TRAY, Pack Number MNS10875; 46) OB DELIVERY TRAY, Pack Number MNS10875A; 47) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 48) BIOPSY TRAY, Pack Number P151659; 49) ARTHROGRAM PACK, Pack Number P241108; 50) ARTHROGRAM TRAY, Pack Number SPEC0004C; 51) RADIOLOGY PACK-LF, Pack Number SPEC0127; 52) ARTHROGRAM TRAY, Pack Number SPEC0143A; 53) BIOPSY TRAY, Pack Number SPEC0148; 54) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 55) LUMBAR TRAY, Pack Number SPEC0177; 56) DR COPPEL FACET TRAY, Pack Number SPEC0178A; 57) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 58) LUMBAR TRAY, Pack Number SPEC0197D; 59) ARTHROGRAM TRAY, Pack Number SPEC0221A; 60) ARTHROGRAM TRAY, Pack Number SPEC0232; 61) 22G FACET TRAY, Pack Number SPEC0265A; 62) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289; 63) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 64) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 65) BIOPSY TRAY-LF, Pack Number SPEC4380; 66) LACERATION TRAY, Pack Number SUT18080; 67) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 68) UMBILICAL VESSEL TRAY, Pack Number UVT1100A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code PWY·April 8, 2024
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A; d. ECMO PACK, Model Number: DYNJ61243; e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A; f. EH TAVR PACK, Model Number: DYNJ57449A; g. ELVS PACK-LF, Model Number: DYNJ26940G; h. ENDO AAA HYBRID CHRG, Model Number: DYNJ60126; i. ENDOVASCULAR OR PACK, Model Number: DYNJ54265; j. ENDOVASCULAR PACK, Model Number: DYNJ59085; k. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831D; l. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435C; m. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456B; n. ENDOVENOUS CORE PACK, Model Number: DYNJ59168; o. ENDOVENOUS PACK, Model Number: DYNJ58228; p. ENS BIOPSIE THYROIDE-HEJ-LF, Model Number: DYNJ62443; q. EP LAB, Model Number: DYNJ59392C; r. EP MERCY JANESVILLE, Model Number: DYNJ907013; s. EP PACK, Model Number: DYNJ57594A; t. EVAR, Model Number: DYNJ900005L; u. EVLA PACK, Model Number: DYNJ66258; v. EVLT, Model Number: DYNJ62417, DYNJ64336; w. EVLT CORE PACK, Model Number: DYNJ45294; x. EVLT PACK, Model Number: DYNJ38674A, DYNJ45997C, DYNJ56548B, DYNJ65995, DYNJ65995A, DYNJ66005; y. FEM POP PACK, Model Number: DYNJ01964M, DYNJ67487A; z. FETAL OPEN/EXIT, Model Number: DYNJ904069C; aa. FH THORACIC PACK, Model Number: DYNJ58572B, DYNJ58572C; bb. FISTULAGRAM/C-ACCESS PACK, Model Number: DYNJ59657A; cc. FLAP, Model Number: DYNJ905146A; dd. FREE FLAP PACK CTX, Model Number: DYNJ68380C; ee. FREE FLAP PACK-LF, Model Number: DYNJ0271254P; ff. FREE FLAP TRAM ADD ON PACK, Model Number: DYNJ82179; gg. GEL ULTRASOUND 20G FOIL , Model Number: DYNJZ45357; hh. GENERAL USE PACK, Model Number: DYNJ41137B; ii. GU ROBOTIC PACK-LF, Model Number: DYNJ0972464Y; jj. GYN LITHOTOMY, Model Number: DYNJ906579C; kk. HH VARITHENA VEIN PACK, Model Number: DYNJ59500; ll. HH VEIN CLOSURE PACK, Model Number: DYNJ59501; mm. HH VEIN PICC MADISON PACK, Model Number: DYNJ59508; nn. HILLCREST PCNL PACK, Model Number: DYNJ69204B; oo. HL VEIN STRIPPING PACK, Model Number: DYNJ40374A; pp. HYBRID KIT, Model Number: DYNJ905335; qq. HYBRID OR PACK, Model Number: SYNJ10303B; rr. I.R. PACK, Model Number: DYNJ60343A; ss. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708F; tt. IR MINI KIT, Model Number: DYNJ44519F; uu. IR NEURO PACK, Model Number: DYNJ39198I; vv. IR PERIPHERAL PACK, Model Number: DYNJ45033A; ww. IR SONO PACK, Model Number: DYNDA2365, DYNDA2365B; xx. JBMH EVAR PACK, Model Number: DYNJ69820; yy. JOHNSON OH ACCESSORY PACK, Model Number: DYNJ51927A; zz. JUDKINS PACK-LF, Model Number: DYNJ0530948AR, DYNJ0586030P; aaa. JVL-PACK TUNNELED, Model Number: DYNJ66065; bbb. KF PACK, Model Number: DYNJ57547, DYNJ58647, DYNJ60127A; ccc. KF PACK 2.0, Model Number: DYNJ69619; ddd. KIDNEY CDS, Model Number: DYNJ903873C; eee. KIDNEY TRANSPLANT, Model Number: DYNJ905682; fff. KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173B; ggg. KIT LB OPEN HEART, Model Number: DYNJ902261D, DYNJ904401B; hhh. KT TAVR PACK, Model Number: DYNJ56283B; iii. LARGE PROCEDURE PACK, Model Number: DYNJ35524D; jjj. LASER ABLATION, Model Number: DYNJ80299; kkk. LASER KIT, Model Number: DYNJ64075A; lll. LASER PACK, Model Number: DYNJ39053A; mmm. LINE KIT, Model Number: DYNJ47987B; nnn. LINE PLACEMENT PACK-LF, Model Number: DYNJ0931376F; ooo. LIVER 2018, Model Number: DYNJ905655, DYNJ905655B; ppp. LIVER TRANSPLANT CDS, Model Number: CDS984951D; qqq. LIVER TRANSPLANT PACK, Model Number: DYNJ0271349T; rrr. LONESTAR RF PACK, Model Number: DYNJ83152; sss. MAD PERIPHERAL VASCULAR-LF, Model Number: DYNJ902168D; ttt. MAG FREE FLAP CDS-LF,
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·May 15, 2023
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
FDA Recall
Open, Classified
·Product code FMH·January 7, 2026
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
FDA Recall
Open, Classified
·Custom Medical Specialties, Inc.·Product code FCH·September 20, 2016
Basic Biopsy Tray, Item Number NMBP44L
FDA Recall
Open, Classified
·American Contract Systems Inc.·Product code FCH·September 4, 2025
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FETOSCOPY, Model Number DYNJ906905B
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·May 18, 2023
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·December 27, 2022
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
FDA Recall
Open, Classified
·NIPRO Technical Services, Inc.·Product code FKH·December 12, 2025
Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A; 6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A; 7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH; 8) PACK,BREAST BIOPSY, Pack Number DYNDL1498; 9) BONE MARROW PACK, Pack Number DYNJ0628436I ; 10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K; 11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH; 12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ; 13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH; 14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ; 15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ; 16) BIOPSY TRAY , Pack Number DYNJ31585C ; 17) BONE MARROW KIT PK, Pack Number DYNJ37526; 18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ; 19) CUSTOM BONE CEMENT TRAY-LF, Pack Number DYNJ42702D ; 20) LIVER TRANSPLANT PACK , Pack Number DYNJ43493A ; 21) BIOPSY TRAY , Pack Number DYNJ49368; 22) BONE MARROW HARVEST PACK, Pack Number DYNJ50740A ; 23) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550; 24) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550A ; 25) NDN CUSTOM BONE RECOVERY, Pack Number DYNJ903942D; 26) MODULE BREAST BIOPSY, Pack Number DYNJ904158B; 27) PACK,FETOSCOPY, Pack Number DYNJ906905B; 28) MINOR/BREAST BIOPSY-LF, Pack Number DYNJS3035; 29) BREAST BIOPSY-LF, Pack Number DYNJT1911D ; 30) BIOPSY TRAY , Pack Number SPEC0150 ; 31) BIOPSY TRAY W/O LIDOCAINE , Pack Number SPEC0196B; 32) STEREOTACTIC BIOPSY TRAY, Pack Number SPEC0279
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·April 8, 2024
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·November 17, 2022
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·May 15, 2023
Sterile Procedural Trays, labeled as the following: LS MS PACK
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FMH·November 17, 2022
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code FMH·October 19, 2023
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
FDA Recall
Open, Classified
·Product code FMH·March 19, 2026
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
FDA Recall
Open, Classified
·American Contract Systems, Inc.·Product code FCH·November 29, 2023
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FMH·February 23, 2024
Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ58575C ; 6) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212H ; 7) FLAP HARVEST PACK, Pack Number DYNJ58575C
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FMH·April 8, 2024
American Contract Systems Biopsy Drape Pack convenience kit
FDA Recall
Open, Classified
·American Contract Systems, Inc.·Product code FCH·May 6, 2024