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    smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ; 4) BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/080CZ; 5) BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/085CZ; 6) BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/090CZ; 7) BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/100CZ; 8) BLUSELECT 6.0, CUFFED, FEN, 10/BX, Item Number 101/802/060CZ; 9) BLUSELECT 7.0, CUFFED, FEN, 10/BX, Item Number 101/802/070CZ; 10) BLUSELECT 7.5, CUFFED, FEN, 10/BX, Item Number 101/802/075CZ; 11) BLUSELECT 8.0, CUFFED, FEN, 10/BX, Item Number 101/802/080CZ; 12) BLUSELECT 8.5, CUFFED, FEN, 10/BX, Item Number 101/802/085CZ; 13) BLUSELECT 9.0, CUFFED, FEN, 10/BX, Item Number 101/802/090CZ; 14) BLUSELECT 10.0, CUFFED, FEN, 10/BX, Item Number 101/802/100CZ; 15) BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/060CZ; 16) BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/070CZ; 17) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075; 18) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075CZ; 19) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080; 20) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080CZ; 21) BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/085CZ; 22) BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/090CZ; 23) BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/100CZ; 24) BLUSELECT 6.0, CUFFED, FEN, 1/EA, Item Number 101/812/060CZ; 25) BLUSELECT 7.0, CUFFED, FEN, 1/EA, Item Number 101/812/070CZ; 26) BLUSELECT 7.5, CUFFED, FEN, 1/EA, Item Number 101/812/075CZ; 27) BLUSELECT 8.0, CUFFED, FEN, 1/EA, Item Number 101/812/080CZ; 28) BLUSELECT 8.5, CUFFED, FEN, 1/EA, Item Number 101/812/085CZ; 29) BLUSELECT 9.0, CUFFED, FEN, 1/EA, Item Number 101/812/090CZ; 30) BLUSELECT 10.0, CUFFED, FEN, 1/EA, Item Number 101/812/100CZ; 31) BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/060; 32) BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/070; 33) BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/075; 34) BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/080; 35) BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/085; 36) BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/090; 37) BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/100; 38) BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/060; 39) BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/070; 40) BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/080; 41) BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/090; 42) BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/100; 43) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/060CZ; 44) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/070CZ; 45) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/075CZ; 46) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/080CZ; 47) BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/085CZ; 48) BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/090CZ; 49) BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/100CZ; 50) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/060CZ; 51) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/070CZ; 52) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/075CZ; 53) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/0

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 18, 2024

    COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.

    FDA Enforcement
    Class II ·Ongoing·Covidien LLC·June 10, 2026

    Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SPONGE 4" X 4" 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) TUR Y SET 81 " 2.1M REGULAR CLAM (1) GOWN SURG REINFORCED LGE TOWEL & WRAP (1) TUBE SUCTION CONNE 1/4 X 12' UF (3) GEL SYRINGE 10cc PREFILLED (1) TABLE COVER REINFORCED 44 X 78 (1) SYRINGE 60ML LUER LOCK W/O NDL UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRAPE,FEMORAL,RADIAL,5/CS; DRAPE,C-SECTION,FEN,CLR SCREEN,WIRE,7/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,U,ORTHOMAX,6/CS; DRAPE,SPLIT,77X120",10/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS. Sterile surgical drape.

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 26, 2025

    UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (1) TUR Y SET, 81 "2 .1M REGULAR CLAM (1) TABLE COVER 44" x 90" (1) DRAPE LITHO 11 0" X 63" WITH POUCH /LEGGING FEN (1) TUBE SUCTION CONNECT. Y." X 12' LIF (1) WASH BASIN ROUND 6QT (1 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (1) BAG URINARY DRAINAGE 2000ml ANTI-REFLUX LIF (1) DRAPE LASER CAMERA W/EL UF (1) SYRINGE 1 Occ W/0 NDL LUER LOCK UF (1 ) UTILITY BOWL 32oz. (1) GEL SYRINGE 10cc PREFILLED (5) SPECIMEN CONTAINER 4oz. W/LID & LABEL L/F (1) WRAPPER 20" X 20" L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE SUCTION CONNECT. W' X 12' LIF (1) GOWN SURG REINF XL T/WRAP (20) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) PENCIL CAUTERY HAND SWITCHING (1) PVP PAINT 8" STICK SPONGE (1) PVP SCRUB 8" STICK SPONGE (1) SYRINGE 20cc W/0 NDL LUER LOCK LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) PRE PAD WITH CUFF (1) PACKING VAGINAL XRD 4" X 36" 8PLY (2) PAD OBSTETRICAL XL (1) CATHETER 2/W 16Fr. PRESS W/UBAG 2000ML (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine Sample 25 Tests Model Number: DOA-1127-041-19. c. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (OX, pH, SG) Urine Sample 25 Tests Model Number: I-DUA-157-013. d. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 6-Drug Panel with Adulterants AMP, BZO, COC, mAMP/MET, OPI, THC, (OX, pH, SG) Urine Sample Tests Model Number: I-DUA-167-022. e. Alere Drugs of Abuse Test iCup Dx Pro 2 10-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, OPI300, OXY, MTD, THC (CR, OX, SG) Urine Sample 25 Tests Model Number: I-DXP-2107-01. f. Alere Drugs of Abuse Test iScreen 5-Drug Panel AMP, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: IS5M. g. Instant Technologies, Inc. Drugs of Abuse Test T-Cube 7-Drug Panel AMP50, COC20, mAMP/MET50, OPI40, OXY20, PCP10, THC40 Saliva Sample 25 Tests Model Number: TCUBE-7PCPB. h. Wondfo Drugs of Abuse Test with Adulterants Tcup 14-Drug Panel AMP1000, BAR300, BZO300, BUP10, COC300, mAMP/MET1000, MDMA500, MTD300, MOP(OPI300), OXY100, PCP25, PPX300, TCA1000, THC50 (CR, pH, SG) Urine Sample 25 Tests Model Number: TDOA-1145A3. i. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, TCA, THC, (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCUPA-12CLIA. j. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, THC (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCupA-12BUP300. k. Alere Drugs of Abuse Test E-Z Split Key Cup 6-Drug Panel AMP, BZO, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: DOA-2167-019. l. Alere Drugs of Abuse Test E-Z Split Key Cup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (CR, GL, NI, OX, pH, SG) Urine Sample 25 Tests Model Number: DUD-157-012-019. m. WONDFO USA CO., LTD. Wondfo Drug Test Dip Card Drugs of Abuse Test Tdip Single Drug Buprenorphine (BUP) Urine Sample 25 Tests Model Number: WDBU-114.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLC; 5 ) KIT, EAR , Catalog Number: PE30EAGT6; 6 ) KIT, EAR , Catalog Number: PE30EAGT7; 7 ) KIT, EAR , Catalog Number: PE30EAGT8; 8 ) KIT, EAR , Catalog Number: PE30EAGT9; 9 ) KIT, EAR , Catalog Number: PE30EAGTB; 10 ) KIT, EAR , Catalog Number: PE30EAGTC; 11 ) KIT, EAR , Catalog Number: PE30EAGTD; 12 ) KIT, NASAL , Catalog Number: PE35NSB10; 13 ) KIT, NASAL , Catalog Number: PE35NSB11; 14 ) KIT, NASAL , Catalog Number: PE35NSB12; 15 ) KIT, NASAL , Catalog Number: PE35NSB13; 16 ) KIT, NASAL , Catalog Number: PE35NSB14; 17 ) KIT, NASAL , Catalog Number: PE35NSB15; 18 ) KIT, NASAL , Catalog Number: PE35NSB16; 19 ) KIT, NASAL , Catalog Number: PE35NSB17; 20 ) KIT, NASAL , Catalog Number: PE35NSB18; 21 ) KIT NASAL , Catalog Number: PE35NSB19; 22 ) KIT, NASAL , Catalog Number: PE35NSBL1; 23 ) KIT, NASAL , Catalog Number: PE35NSBL2; 24 ) KIT, NASAL , Catalog Number: PE35NSBL3; 25 ) KIT, NASAL , Catalog Number: PE35NSBL4; 26 ) KIT, NASAL , Catalog Number: PE35NSBL5; 27 ) KIT, NASAL , Catalog Number: PE35NSBL6; 28 ) KIT, NASAL , Catalog Number: PE35NSBL7; 29 ) KIT, NASAL , Catalog Number: PE35NSBL8; 30 ) KIT, NASAL , Catalog Number: PE35NSBL9; 31 ) KIT, NASAL , Catalog Number: PE35NSBLA; 32 ) KIT, NASAL , Catalog Number: PE35NSBLB; 33 ) KIT, NASAL , Catalog Number: PE35NSBLC; 34 ) KIT NASAL , Catalog Number: PE35NSBLD; 35 ) KIT, NASAL , Catalog Number: PE35NSBLF; 36 ) KIT, SINUS , Catalog Number: PE3ESKSG1; 37 ) KIT, SINUS , Catalog Number: PE3ESKSG2; 38 ) KIT, SINUS , Catalog Number: PE3ESKSGA; 39 ) KIT, SINUS , Catalog Number: PE3ESKSGB; 40 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU4; 41 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU5; 42 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU6; 43 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU7; 44 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUH; 45 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUI; 46 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNH3; 47 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNHE; 48 ) KIT,ORP MAJOR EAR , Catalog Number: PEHDMJVCG; 49 ) KIT,ENT, SW , Catalog Number: PEMHETMHA; 50 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH1; 51 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH2; 52 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHA; 53 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB10; 54 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB11; 55 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH4; 56 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH5; 57 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH6; 58 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH7; 59 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH8; 60 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH9; 61 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHP; 62 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHQ; 63 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHR; 64 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL011; 65 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL012; 66 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL01A; 67 ) KIT,NASAL SINUS ,PRESBYTERIAN , Catalog Number: PEV2CL102; 68 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL103; 69 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL104; 70 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL105; 71 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL106; 72 ) KIT,NASAL SINUS , PRESBYTERIAN , C

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·January 22, 2025

    Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414; 6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R; 7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG; 8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416; 9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417; 10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418; 11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419; 12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462; 13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491; 14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492; 15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498; 16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003; 17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG; 18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008; 19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG; 20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009; 21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101; 22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A; 23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG; 24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103; 25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109; 26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002; 27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003; 28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106; 29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119; 30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215; 31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002; 32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006; 33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001; 34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003; 35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002; 36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG; 37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003; 38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG; 39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005; 40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG; 41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201; 42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG; 43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211; 44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301; 45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A; 46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG; 47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412; 48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG; 49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414; 50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001; 51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103; 52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901; 53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902; 54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414; 6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R; 7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG; 8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416; 9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417; 10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418; 11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419; 12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462; 13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491; 14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492; 15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498; 16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003; 17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG; 18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008; 19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG; 20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009; 21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101; 22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A; 23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG; 24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103; 25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109; 26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002; 27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003; 28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106; 29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119; 30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215; 31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002; 32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006; 33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001; 34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003; 35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002; 36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG; 37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003; 38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG; 39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005; 40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG; 41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201; 42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG; 43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211; 44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301; 45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A; 46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG; 47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412; 48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG; 49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414; 50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001; 51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103; 52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901; 53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902; 54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 25, 2026

    Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/CT systems.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·August 17, 2022

    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 Enforcement
    Class III ·Terminated·Gen-Probe Inc·June 25, 2014

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    FDA Enforcement
    Class II ·Terminated·Derma Pen, LLC·September 16, 2015

    DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01

    FDA Enforcement
    Class II ·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024

    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

    FDA Enforcement
    Class II ·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024

    DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01

    FDA Enforcement
    Class II ·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024

    Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE LITHOMIE MINEURE-LF, Model Number: DYNJ47552C; 6) CH D&C PACK, Model Number: DYNJ67945; 7) LAP GYN PACK-LF, Model Number: DYNJ25892K; 8) GYN LAPAROSCOPY PACK BJC-LF, Model Number: DYNJ41670B; 9) OPP GYN VAGINAL PACK, Model Number: DYNJ67227; 10) GYNE MINOR LAPAROSCOPY GRH-LF, Model Number: DYNJ41790F; 11) GYNE - LITHOTOMY MINOR PACK-LF, Model Number: DYNJ49251C; 12) STANDARD D&C, Model Number: DYNJ69733; 13) PERI GYN PACK, Model Number: DYNJ24338I; 14) GYN LAPAROSCOPY CDS, Model Number: CDS982727L; 15) ROBOTICS, Model Number: DYNJ908712B

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025