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Recreo Hair Growth Laser Comb

FDA Enforcement
Class II ·Ongoing·OMM Imports, Inc. dba Zero Gravity·March 22, 2023

Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack Number CMPJ09914C; 7) ENT PACK, Pack Number CMPJ13389A; 8) ENT PACK, Pack Number CMPJ13389B; 9) ENT PACK, Pack Number CMPJ13389C; 10) DR LIN EAR PACK , Pack Number CMPJ13509 ; 11) TYMPANOPLASTY PACK, Pack Number CMPJ21114O; 12) EAR PACK-LF , Pack Number DYNJ0425965G ; 13) EAR PACK-LF , Pack Number DYNJ0774664K ; 14) HL EAR PACK , Pack Number DYNJ40560B; 15) HL EAR PACK , Pack Number DYNJ40560BH; 16) EAR PACK, Pack Number DYNJ44134C; 17) EAR PACK, Pack Number DYNJ44134D; 18) EAR PACK, Pack Number DYNJ44134F; 19) MINOR ENT PACK, Pack Number DYNJ45577A; 20) ENT PACK, Pack Number DYNJ48595 ; 21) MH NASAL, Pack Number DYNJ49888I; 22) MH NASAL, Pack Number DYNJ49888J; 23) MIDDLE EAR OR , Pack Number DYNJ52583G; 24) MIDDLE EAR OR , Pack Number DYNJ52583J; 25) MIDDLE EAR OR , Pack Number DYNJ52583L; 26) ***, Pack Number DYNJ52583M; 27) GLENNON HEAD AND NECK PACK-LF , Pack Number DYNJ57200A; 28) MIDDLE EAR PACK , Pack Number DYNJ65935A; 29) ENT PACK, Pack Number DYNJ66039B; 30) FACIAL PACK , Pack Number DYNJ82177B; 31) FACIAL PACK , Pack Number DYNJ82177BH; 32) EAR CUSTOM PACK , Pack Number DYNJ82564 ; 33) ***, Pack Number DYNJ86113 ; 34) EAR , Pack Number DYNJ901779J; 35) MZ EAR CDS, Pack Number DYNJ905642D; 36) PACK MAJOR EAR CHRG , Pack Number DYNJ905694C; 37) ENT , Pack Number DYNJ909128A; 38) ENT , Pack Number DYNJ909128C; 39) ENT , Pack Number DYNJ909128D; 40) ***, Pack Number DYNJ909128D; 41) DR LIN EAR, Pack Number DYNJ909251; 42) T AND A , Pack Number DYNJ909941; 43) ***, Pack Number DYNJ909941

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 29, 2026

Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIOTOMY CDS-LF, REF CDS780105M; 8) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 9) CRANIOTOMY CDS, REF CDS780166Q; 10) ANTERIOR CERVICAL CDS, REF CDS780205O; 11) ANTERIOR CERVICAL CDS, REF CDS780205P; 12) ANTERIOR CERVICAL CDS, REF CDS780205Q; 13) CRANIOTOMY CDS, REF CDS780206O; 14) CRANIOTOMY CDS, REF CDS780206P; 15) CRANIOTOMY CDS, REF CDS780206R; 16) NEURO-LAMI CDS, REF CDS780208I; 17) SHY CRANIOTOMY CDS, REF CDS780214M; 18) SHY CRANIOTOMY CDS, REF CDS780214N; 19) SPINAL CDS, REF CDS940087AL; 20) ORTHO SPINE PROCEDURE, REF CDS940875P; 21) CRANIOTOMY-RICHMOND, REF CDS980929Q; 22) CRANIOTOMY-RICHMOND, REF CDS980929R; 23) CRANIOTOMY-RICHMOND, REF CDS980929S; 24) CRANIOTOMY-RICHMOND, REF CDS980929T; 25) CRANIOTOMY-RICHMOND, REF CDS980929U; 26) OMC LUMBAR CDS, REF CDS981062I; 27) LAMINECTOMY CDS, REF CDS981229A; 28) ORTHO SPINE SUPPLEMENTAL CDS, REF CDS981742M; 29) CRANIOTOMY CDS, REF CDS981888X; 30) ANTERIOR CERVICAL DISC, REF CDS982023S; 31) ANTERIOR CERVICAL DISC, REF CDS982023T; 32) CRANIOTOMY, REF CDS982029R; 33) CRANIOTOMY, REF CDS982029S; 34) LAMI FUSION, REF CDS982035T; 35) LAMI FUSION, REF CDS982035U; 36) MICRODISCECTOMY, REF CDS982054W; 37) CRANIOTOMY CDS, REF CDS982480L; 38) CRANIOTOMY CDS, REF CDS982480M; 39) CRANIOTOMY CDS, REF CDS982480N; 40) CRANIOTOMY CDS, REF CDS982480O; 41) CRANIOTOMY CDS, REF CDS982480P; 42) LAMINECTOMY CDS, REF CDS982491L; 43) LAMINECTOMY CDS, REF CDS982491M; 44) LAMINECTOMY CDS, REF CDS982491N; 45) LAMINECTOMY CDS, REF CDS982491O; 46) LAMINECTOMY CDS, REF CDS982491P; 47) LAMINECTOMY CDS, REF CDS982491Q; 48) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563C; 49) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563D; 50) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563F; 51) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563G; 52) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563I; 53) NEURO SPINE CDS, REF CDS982683O; 54) NEURO SPINE CDS, REF CDS982683P; 55) NEURO SPINE CDS, REF CDS982683R; 56) NEURO SPINE CDS, REF CDS982683S; 57) NEURO SPINE CDS, REF CDS982683U; 58) NEURO SPINE CDS, REF CDS982683V; 59) NEURO SPINE, REF CDS982683W; 60) CRANIOTOMY, REF CDS982719P; 61) CRANIOTOMY, REF CDS982719Q; 62) CRANIOTOMY, REF CDS982719R; 63) CRANIOTOMY, REF CDS982719S; 64) CRANIOTOMY, REF CDS982719T; 65) CRANIOTOMY, REF CDS982719U; 66) CRANIOTOMY, REF CDS982719V; 67) CRANIOTOMY, REF CDS982719W; 68) ORTHO SPINE, REF CDS982735M; 69) ORTHO SPINE, REF CDS982735N; 70) ORTHO SPINE, REF CDS982735O; 71) ORTHO SPINE, REF CDS982735Q; 72) ORTHO SPINE, REF CDS982735R; 73) ORTHO SPINE, REF CDS982735S; 74) ORTHO SPINE, REF CDS982735U; 75) SPINAL CDS, REF CDS983037J; 76) SPINAL CDS, REF CDS983037K; 77) CRANIOTOMY CDS, REF CDS983094D; 78) CERVICAL SPINE CDS, REF CDS983108F; 79) LAMINECTOMY CDS, REF CDS983115F; 80) ZALE SPINE CDS, REF CDS983182F; 81) ZALE SPINE CDS, REF CDS983182G; 82) ZALE SPINE CDS, REF CDS983182I; 83) ZALE SPINE CDS, REF CDS983182J; 84) ZALE SPINE CDS, REF CDS983182K; 85) ZALE SPINE CDS, REF CDS983182L; 86) ZALE SPINE CDS, REF CDS983182M; 87) ZALE CRANIOTOMY CDS, REF CDS983188F; 88) ZALE CRANIOTOMY CDS, REF CDS983188K; 89) CRANIOTOMY, REF CDS983349J; 90) CRANIOTOMY, REF CDS983349K; 91) CRANIOTOMY, REF CDS983349L; 92) CRANIOTOMY, REF CDS983349M; 93) CRANIOTOMY, REF CDS983349N; 94) CRANIOTOMY, REF CDS983349O; 95) CRANI CDS, REF CDS983386G; 96) CRANIOTOMY CDS, REF CDS983467D; 97) CRANIOTOMY CDS, REF CDS983467F; 98) CRANIOTOMY CDS, REF CDS983467G; 99) CRANIOTOMY CDS, REF CDS983467I; 100) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476D; 101) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476F; 102) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476G; 103) LUMBAR LAMINECTOMY NEURO CDS, REF CDS98

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 8, 2025