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REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

FDA Enforcement
Class II ·Ongoing·Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.·January 31, 2024

Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39301HCTS/CAMERA TRAY (STERRAD, STANDARD CAMERA HEADS); 39301PHTS/CAMERA TRAY (STERRAD, PENDULUM/INLINE CAM HEADS); 39305C1S/BASKET-STYLE RIGID TELESCOPE TRAY (UDEL, 1 RIGID SCOPE 4MM X 30CM); 39305C2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39305L1S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE); 39305L2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39311AS/RIGID TELESCOPE TRAY (STERRAD, 4 RIGID SCOPES & LT CABLE); 39311BS/RIGID TELESCOPE TRAY (STERRAD, TWO LAP SCOPES/CABLE); 39314FS/RIGID TELESCOPE TRAY (STERRAD, FOUR LAP SCOPES/CABLE); 39401AS/FLEXIBLE ENDOSCOPE TRAY (UP TO 39CM); 39402AS/FLEXIBLE ENDOSCOPE TRAY (FIBERSCOPES); 39403AS/FLEXIBLE ENDOSCOPE TRAY (CCD VIDESCOPES); 39406AS/FLEXIBLE ENDOSCOPE TRAY (CMOS VIDEOSCOPES)

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code KCT·October 15, 2021

REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

FDA Recall
Open, Classified ·Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. Akcaburgaz Mahallesi Muhsin Yazicioglu Caddesi No:45/5 Esenyurt Turkey·Product code MUI·June 9, 2023

ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT 1 5" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF ( 1 ) DRAPE SHEET 70" X 100" L/ F (5) LAP SPONGE PREWASH 18" X 1 8" XRD LIF (1 ) MAYOTRAYLARGE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SKIN STAPLER WIDE 35 LIF ( 1) DRAPE INCISE ANTI M I CROBIAL 23" X 1 7" LIF (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 2 1 " LIF (1 ) PAD ABDOM INAL 8" X 7"h.'' (1) YAUNKAUER SUCTION TUBE WITHOUT VENT LIF (1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 ) BLADE SURG ICAL #10 STAINLESS STEEL (I) SPLIT SHEET WITH ADHESIVE 108" X 77" STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX ( I ) *Pr. GLOVE# 8 SURGEON NEUTRALON LATEX ( I ) GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI Ill (3) GOWN XL SMS IM PERVIOUS REINFORCED AAM I III LIF ( I ) CAUTERY PENCIL ROCK ER SWITCH (2) *Prs. GLOVES SURG. # 8 POWDER (4) Prs. GLOVES SURG. 8.5 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.

FDA Recall
Terminated ·Mako Surgical Corporation·Product code KQM·October 25, 2010

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

FDA Enforcement
Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR CDS-LF k. PLASTIC BREAST CDS-LF l. BREAST-HERNIA-PORT CDS-LF m. DAY SURG PLASTIC CDS n. PLASTIC SURGERY PACK o. PLASTIC PACK-LF p. PLASTIC-GENERAL SURGERY PACK q. PLASTIC PACK-LF r. ABDOMINOPLASTY/BREAST s. PLASTIC PACK t. BREAST PACK u. PLASTIC SURGERY TRAY v. BREAST AUGMENTATION PACK w. FACE PACK x. LIPOSUCTION PACK y. UNIVERSAL PLASTIC PACK z. PLASTIC PACK aa. LIPOSUCTION PACK bb. MINOR BREAST PACK cc. PLASTICS PACK-LF dd. UPPER PLASTIC PACK-LF ee. BREAST MAJOR PACK-LF ff. CAM PARTIAL MASTECTOMY PACK gg. PLASTIC PACK hh. BREAST PACK ii. BREAST RECONS COMBO PK XM-LF jj. PLASTICS PACK kk. BREAST REDUCTION PACK ll. BREAST HERNIA PK mm. T PLASTY PACK nn. ASC PLASTICS PACK oo. PLASTICS PACK-LF pp. OCULOPLASTIC PICK PACK qq. PLASTIC SURGERY LF PACK rr. PLASTIC PACK ss. OCULAR PLASTIC PACK tt. CHEST BREAST PACK uu. BREAST PACK vv. MAJOR PLASTIC PACK ww. FACIAL PLASTICS PACK xx. PLASTIC PACK yy. BREAST PACK zz. CHEST/BREAST PACK aaa. BREAST PACK bbb. BREAST PACK LJ-LF ccc. SCRIPPS SW PLASTIC PACK ddd. BREAST PACK eee. BREAST PACK fff. PLASTIC SURGERY U-BAR PACK ggg. PHOENIXVILLE BREAST PACK hhh. LAB PLASTIC PACK #DF2 iii. PLASTIC PACK jjj. GENERAL PLASTIC PACK kkk. CHEST/BREAST lll. MAJOR PLASTIC PACK mmm. MAJOR BREAST PACK nnn. BREAST ABDOMINOPLASTY PACK ooo. DR HOLCOMB FACIAL PACK ppp. MAJOR PLASTIC BREAST PACK qqq. DIAZ PACK rrr. BREAST PACK sss. BREAST PACK ttt. CHEST PACK uuu. PLASTIC FACIAL PACK vvv. FACIAL PLASTICS PACK www. BLEPHAROPLASTY PACK xxx. BREAST PACK - MOISES yyy. PLASTIC PACK zzz. PLASTIC PACK aaaa. BREAST AUGMENTATION PACK bbbb. CHEST/BREAST cccc. BREAST PACK dddd. PLASTIC PACK eeee. PLASTICS PACK ffff. PLASTIC PACK gggg. CHEST BREAST PACK hhhh. PLASTIC PACK iiii. CAROLINA FACIAL PLASTIC PACK jjjj. BREAST PACK kkkk. CHEST BREAST PACK llll. BREAST DBL PROCED SUPPLEMENT mmmm. BREAST PACK nnnn. PLASTIC PACK oooo. PLASTICS PACK pppp. ESC PLASTICS PACK qqqq. FACE LIFT PACK rrrr. CHEST BREAST ssss. BREAST PACK tttt. MINOR PLASTIC PACK uuuu. #2 FACIAL PLASTY PACK vvvv. BBL PACK wwww. BASIC PACK xxxx. BREAST PACK yyyy. BREAST AUGMENTATION PACK zzzz. BREAST PACK aaaaa. MAJOR BREAST OR UNIVERSAL bbbbb. CHEST/BREAST-LF ccccc. CUSTOM PLASTIC PACK ddddd. CHEST/BREAST PACK eeeee. PLASTIC GENERAL PACK fffff. SPECIALTY FACIAL PLASTICS PACK ggggg. OCCULOPLASTICS PACK hhhhh. BREAST PACK iiiii. LIPOSUCTION PACK jjjjj. BREAST PACK kkkkk. PLASTICS PACK lllll. BREAST PACK mmmmm. BREAST REDUCTION PACK nnnnn. BREAST AUGMENTATION PACK ooooo. FACE/RHINOPLASTY PACK ppppp. BREAST PACK qqqqq. TUMMY TUCK PACK rrrrr. BREAST PACK sssss. PLASTICS PACK ttttt. BREAST/ABDOMINAL PACK uuuuu. PLASTIC PACK vvvvv. BREAST PACK wwwww. RECONSTRUCTION PACK xxxxx. PLASTIC PACK yyyyy. PLASTICS PACK zzzzz. PLASTICS PACK aaaaaa. GENERAL PLASTIC-LF bbbbbb. PLASTIC UNIVERSAL cccccc. BREAST HA-LF dddddd. BREAST eeeeee. PLASTIC ffffff. BREAST gggggg. MAJOR BREAST hhhhhh. CHEST/BREAST-MRMCASU iiiiii. BREAST RECONSTRUCTION PACK jjjjjj. CHEST/BREAST kkkkkk. BREAST PACK llllll. BREAST BIOPSY/MASTECTOMY mmmmmm. CHEST/BREAST-LF

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR CDS-LF k. PLASTIC BREAST CDS-LF l. BREAST-HERNIA-PORT CDS-LF m. DAY SURG PLASTIC CDS n. PLASTIC SURGERY PACK o. PLASTIC PACK-LF p. PLASTIC-GENERAL SURGERY PACK q. PLASTIC PACK-LF r. ABDOMINOPLASTY/BREAST s. PLASTIC PACK t. BREAST PACK u. PLASTIC SURGERY TRAY v. BREAST AUGMENTATION PACK w. FACE PACK x. LIPOSUCTION PACK y. UNIVERSAL PLASTIC PACK z. PLASTIC PACK aa. LIPOSUCTION PACK bb. MINOR BREAST PACK cc. PLASTICS PACK-LF dd. UPPER PLASTIC PACK-LF ee. BREAST MAJOR PACK-LF ff. CAM PARTIAL MASTECTOMY PACK gg. PLASTIC PACK hh. BREAST PACK ii. BREAST RECONS COMBO PK XM-LF jj. PLASTICS PACK kk. BREAST REDUCTION PACK ll. BREAST HERNIA PK mm. T PLASTY PACK nn. ASC PLASTICS PACK oo. PLASTICS PACK-LF pp. OCULOPLASTIC PICK PACK qq. PLASTIC SURGERY LF PACK rr. PLASTIC PACK ss. OCULAR PLASTIC PACK tt. CHEST BREAST PACK uu. BREAST PACK vv. MAJOR PLASTIC PACK ww. FACIAL PLASTICS PACK xx. PLASTIC PACK yy. BREAST PACK zz. CHEST/BREAST PACK aaa. BREAST PACK bbb. BREAST PACK LJ-LF ccc. SCRIPPS SW PLASTIC PACK ddd. BREAST PACK eee. BREAST PACK fff. PLASTIC SURGERY U-BAR PACK ggg. PHOENIXVILLE BREAST PACK hhh. LAB PLASTIC PACK #DF2 iii. PLASTIC PACK jjj. GENERAL PLASTIC PACK kkk. CHEST/BREAST lll. MAJOR PLASTIC PACK mmm. MAJOR BREAST PACK nnn. BREAST ABDOMINOPLASTY PACK ooo. DR HOLCOMB FACIAL PACK ppp. MAJOR PLASTIC BREAST PACK qqq. DIAZ PACK rrr. BREAST PACK sss. BREAST PACK ttt. CHEST PACK uuu. PLASTIC FACIAL PACK vvv. FACIAL PLASTICS PACK www. BLEPHAROPLASTY PACK xxx. BREAST PACK - MOISES yyy. PLASTIC PACK zzz. PLASTIC PACK aaaa. BREAST AUGMENTATION PACK bbbb. CHEST/BREAST cccc. BREAST PACK dddd. PLASTIC PACK eeee. PLASTICS PACK ffff. PLASTIC PACK gggg. CHEST BREAST PACK hhhh. PLASTIC PACK iiii. CAROLINA FACIAL PLASTIC PACK jjjj. BREAST PACK kkkk. CHEST BREAST PACK llll. BREAST DBL PROCED SUPPLEMENT mmmm. BREAST PACK nnnn. PLASTIC PACK oooo. PLASTICS PACK pppp. ESC PLASTICS PACK qqqq. FACE LIFT PACK rrrr. CHEST BREAST ssss. BREAST PACK tttt. MINOR PLASTIC PACK uuuu. #2 FACIAL PLASTY PACK vvvv. BBL PACK wwww. BASIC PACK xxxx. BREAST PACK yyyy. BREAST AUGMENTATION PACK zzzz. BREAST PACK aaaaa. MAJOR BREAST OR UNIVERSAL bbbbb. CHEST/BREAST-LF ccccc. CUSTOM PLASTIC PACK ddddd. CHEST/BREAST PACK eeeee. PLASTIC GENERAL PACK fffff. SPECIALTY FACIAL PLASTICS PACK ggggg. OCCULOPLASTICS PACK hhhhh. BREAST PACK iiiii. LIPOSUCTION PACK jjjjj. BREAST PACK kkkkk. PLASTICS PACK lllll. BREAST PACK mmmmm. BREAST REDUCTION PACK nnnnn. BREAST AUGMENTATION PACK ooooo. FACE/RHINOPLASTY PACK ppppp. BREAST PACK qqqqq. TUMMY TUCK PACK rrrrr. BREAST PACK sssss. PLASTICS PACK ttttt. BREAST/ABDOMINAL PACK uuuuu. PLASTIC PACK vvvvv. BREAST PACK wwwww. RECONSTRUCTION PACK xxxxx. PLASTIC PACK yyyyy. PLASTICS PACK zzzzz. PLASTICS PACK aaaaaa. GENERAL PLASTIC-LF bbbbbb. PLASTIC UNIVERSAL cccccc. BREAST HA-LF dddddd. BREAST eeeeee. PLASTIC ffffff. BREAST gggggg. MAJOR BREAST hhhhhh. CHEST/BREAST-MRMCASU iiiiii. BREAST RECONSTRUCTION PACK jjjjjj. CHEST/BREAST kkkkkk. BREAST PACK llllll. BREAST BIOPSY/MASTECTOMY mmmmmm. CHEST/BREAST-LF

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FTN·November 17, 2022

Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR PACK-LF n. THORACOTOMY HARPER PACK-LF o. FESS NSR PACK-LF p. ENT BASIC PACK-LF q. HEAD & NECK-LF r. ENT PACK-LF s. SINOSCOPY-LF t. MAJOR HEAD/NECK PACK-LF u. NECK PACK v. HEAD & NECK PACK w. HEAD & NECK TRAY x. ENT LAW PACK-LF y. ENT PACK z. NECK PACK aa. NASAL PACK bb. ENT PACK cc. FREE FLAP PACK-LF dd. TYMPANO MASTOID ee. MINOR HEAD & NECK #40-RF ff. EAR PACK gg. E.N.T. TRAY hh. EAR PACK-LF ii. BASIC ENT PACK-LF jj. PLASTIC HEAD & NECK PACK kk. EAR TRAY #10-RF ll. HEAD & NECK ENT PACK-RF-LF mm. ENT PACK nn. ENT PACK-LF oo. NASAL/SEPTO PACK pp. OSC FACE LIFT PK qq. RRMC NASAL PACK rr. ENT PACK ss. HENRYS ENT PACK tt. ENT uu. FACE AND NASAL PACK vv. NASAL PACK ww. ENT PACK xx. SINUS ENDOSCOPY-LF yy. OSC NASAL-NOSE PACK-LF zz. ENT PACK aaa. FES PACK - LF bbb. HEAD AND NECK PACK ccc. SCRIPPS SW ENT PACK ddd. SCRIPPS SW EAR PACK-LF eee. HL ENT PACK fff. CAROTID ENDARTECTOMY PK ggg. EAR PACK hhh. ENT FREE FLAP iii. HEAD AND NECK PACK jjj. TRACH PACK kkk. HL EAR PACK lll. NASAL SINUS ENDO PK mmm. ENT PACK nnn. HEAD AND NECK PACK ooo. ENT PACK ppp. HEAD AND NECK PACK qqq. ASC HEAD & NECK PACK rrr. ENT PACK sss. DEACONESS HEAD AND NECK PACK ttt. ENT PACK uuu. BEC MOHS PACK vvv. PK,ENT-EAR www. SVMMC HEAD AND NECK PACK xxx. PK, ENT yyy. HEAD AND NECK PACK zzz. FESS PACK aaaa. PK,ENT-SINUS bbbb. NASAL/HEAD & NECK PACK cccc. ENT PACK dddd. ENT PACK eeee. MAJOR ENT PACK ffff. ENT NECK MMC PACK gggg. HEAD AND NECK PACK hhhh. HEAD AND NECK PACK iiii. HEAD AND NECK PACK jjjj. ORAL PACK kkkk. HMT THORACOSCOPY PACK llll. GU PACK mmmm. HEAD NECKPACK (HNSJC)227-LF nnnn. HEAD AND NECK PLUS I PACK oooo. NASAL PACK pppp. HEAD & NECK PACK-RFD-LF qqqq. ENT PACK rrrr. ENT/H&N PACK ssss. C-SECTION PACK tttt. ENT PACK uuuu. ENT PACK vvvv. ENT PACK wwww. NASAL ENT PACK xxxx. SINUS PACK yyyy. HEAD/NECK PACK zzzz. ENT PACK aaaaa. NASAL PACK bbbbb. FESS PACK ccccc. NASAL SEPTOPLASTY PACK ddddd. ENT PACK eeeee. HEAD&NECK fffff. EAR PACK-LF ggggg. HEAD AND NECK PACK-LF hhhhh. EAR BASIC PACK iiiii. HEAD AND NECK PACK jjjjj. ENT/SEPTO PACK kkkkk. ENT PACK lllll. HEAD & NECK PACK mmmmm. HEAD AND NECK PACK nnnnn. ENT PACK ooooo. ENT PACK-LF ppppp. ENT PACK-LF qqqqq. HL DR PETERS ENT PACK rrrrr. RHINO/SEPTO/FESS PACK sssss. HEAD & NECK ttttt. THYROID/PARATHYROID PACK uuuuu. HEAD AND NECK MINOR PACK vvvvv. PK,ENT wwwww. ENT PACK xxxxx. ENT PACK yyyyy. ENT PACK zzzzz. ENT NECK PACK aaaaaa. ENT PACK bbbbbb. NECK PACK cccccc. EAR TRAY dddddd. HEAD & NECK PACK eeeeee. HEAD & NECK PACK ffffff. MHPB HEAD AND NECK PACK gggggg. NASAL PACK hhhhhh. ENT PACK iiiiii. JHOC EAR TRAY jjjjjj. JHOC HEAD TRAY kkkkkk. ENT I llllll. ENT SHARED mmmmmm. ENT PACK nnnnnn. EENT SPLIT PACK-NO GPAD oooooo. ENT PACK pppppp. HEAD & NECK PACK qqqqqq. NASAL PACK rrrrrr. ENT PACK ssssss. ENT PACK tttttt. ENT PACK uuuuuu. ENT PACK vvvvvv. ENT PACK-LF wwwwww. ENT I-LF xxxxxx. MAJOR HEAD AND NECK PACK yyyyyy. HEAD AND NECK PACK zzzzzz. FACE AND NECK aaaaaaa. ENT PACK bbbbbbb. ENT PACK ccccccc. ENT BASIC PACK-LF ddddddd. ENT PACK-LF eeeeeee. PK, ENT-H&N fffffff. ENT PACK ggggggg. SPRINGS HEAD AND NECK PACK hhhhhhh. ENDO SINUS PACK iiiiiii. HEAD/NECK PACK jjjjjjj. ENT/SINUS PACK-LF kkkkkkk. ENT PACK lllllll. NASAL PACK mmmmmmm. ENT PACK nnnnnnn. ORAL PLASTIC FACIAL PACK ooooooo. ENT HEAD NECK PACK ppppppp. THYROIDECTOMY PACK qqqqqqq. MINOR ORL PACK rrrrrrr. EAR CUSTOM PACK sssssss. MG NS ENT PACK ttttttt. HEAD AND NECK PACK uuuuuuu. ENT PACK vvvvvvv. MAJOR ENT PACK wwwwwww. ENT xxxxxxx. NASAL EAR yyyyyyy. NASAL-LF zzzzzzz. LARGE ENT aaaaaaaa. EAR bbbbbbbb. HEAD AND NECK cccccccc. PAD ENT HEAD & NECK dddddddd. FHT CVOR TAVR eeeeeeee. MODULE NASAL NATALIE ffffffff. ENT-LF gggggggg. HEA

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023

Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR PACK-LF n. THORACOTOMY HARPER PACK-LF o. FESS NSR PACK-LF p. ENT BASIC PACK-LF q. HEAD & NECK-LF r. ENT PACK-LF s. SINOSCOPY-LF t. MAJOR HEAD/NECK PACK-LF u. NECK PACK v. HEAD & NECK PACK w. HEAD & NECK TRAY x. ENT LAW PACK-LF y. ENT PACK z. NECK PACK aa. NASAL PACK bb. ENT PACK cc. FREE FLAP PACK-LF dd. TYMPANO MASTOID ee. MINOR HEAD & NECK #40-RF ff. EAR PACK gg. E.N.T. TRAY hh. EAR PACK-LF ii. BASIC ENT PACK-LF jj. PLASTIC HEAD & NECK PACK kk. EAR TRAY #10-RF ll. HEAD & NECK ENT PACK-RF-LF mm. ENT PACK nn. ENT PACK-LF oo. NASAL/SEPTO PACK pp. OSC FACE LIFT PK qq. RRMC NASAL PACK rr. ENT PACK ss. HENRYS ENT PACK tt. ENT uu. FACE AND NASAL PACK vv. NASAL PACK ww. ENT PACK xx. SINUS ENDOSCOPY-LF yy. OSC NASAL-NOSE PACK-LF zz. ENT PACK aaa. FES PACK - LF bbb. HEAD AND NECK PACK ccc. SCRIPPS SW ENT PACK ddd. SCRIPPS SW EAR PACK-LF eee. HL ENT PACK fff. CAROTID ENDARTECTOMY PK ggg. EAR PACK hhh. ENT FREE FLAP iii. HEAD AND NECK PACK jjj. TRACH PACK kkk. HL EAR PACK lll. NASAL SINUS ENDO PK mmm. ENT PACK nnn. HEAD AND NECK PACK ooo. ENT PACK ppp. HEAD AND NECK PACK qqq. ASC HEAD & NECK PACK rrr. ENT PACK sss. DEACONESS HEAD AND NECK PACK ttt. ENT PACK uuu. BEC MOHS PACK vvv. PK,ENT-EAR www. SVMMC HEAD AND NECK PACK xxx. PK, ENT yyy. HEAD AND NECK PACK zzz. FESS PACK aaaa. PK,ENT-SINUS bbbb. NASAL/HEAD & NECK PACK cccc. ENT PACK dddd. ENT PACK eeee. MAJOR ENT PACK ffff. ENT NECK MMC PACK gggg. HEAD AND NECK PACK hhhh. HEAD AND NECK PACK iiii. HEAD AND NECK PACK jjjj. ORAL PACK kkkk. HMT THORACOSCOPY PACK llll. GU PACK mmmm. HEAD NECKPACK (HNSJC)227-LF nnnn. HEAD AND NECK PLUS I PACK oooo. NASAL PACK pppp. HEAD & NECK PACK-RFD-LF qqqq. ENT PACK rrrr. ENT/H&N PACK ssss. C-SECTION PACK tttt. ENT PACK uuuu. ENT PACK vvvv. ENT PACK wwww. NASAL ENT PACK xxxx. SINUS PACK yyyy. HEAD/NECK PACK zzzz. ENT PACK aaaaa. NASAL PACK bbbbb. FESS PACK ccccc. NASAL SEPTOPLASTY PACK ddddd. ENT PACK eeeee. HEAD&NECK fffff. EAR PACK-LF ggggg. HEAD AND NECK PACK-LF hhhhh. EAR BASIC PACK iiiii. HEAD AND NECK PACK jjjjj. ENT/SEPTO PACK kkkkk. ENT PACK lllll. HEAD & NECK PACK mmmmm. HEAD AND NECK PACK nnnnn. ENT PACK ooooo. ENT PACK-LF ppppp. ENT PACK-LF qqqqq. HL DR PETERS ENT PACK rrrrr. RHINO/SEPTO/FESS PACK sssss. HEAD & NECK ttttt. THYROID/PARATHYROID PACK uuuuu. HEAD AND NECK MINOR PACK vvvvv. PK,ENT wwwww. ENT PACK xxxxx. ENT PACK yyyyy. ENT PACK zzzzz. ENT NECK PACK aaaaaa. ENT PACK bbbbbb. NECK PACK cccccc. EAR TRAY dddddd. HEAD & NECK PACK eeeeee. HEAD & NECK PACK ffffff. MHPB HEAD AND NECK PACK gggggg. NASAL PACK hhhhhh. ENT PACK iiiiii. JHOC EAR TRAY jjjjjj. JHOC HEAD TRAY kkkkkk. ENT I llllll. ENT SHARED mmmmmm. ENT PACK nnnnnn. EENT SPLIT PACK-NO GPAD oooooo. ENT PACK pppppp. HEAD & NECK PACK qqqqqq. NASAL PACK rrrrrr. ENT PACK ssssss. ENT PACK tttttt. ENT PACK uuuuuu. ENT PACK vvvvvv. ENT PACK-LF wwwwww. ENT I-LF xxxxxx. MAJOR HEAD AND NECK PACK yyyyyy. HEAD AND NECK PACK zzzzzz. FACE AND NECK aaaaaaa. ENT PACK bbbbbbb. ENT PACK ccccccc. ENT BASIC PACK-LF ddddddd. ENT PACK-LF eeeeeee. PK, ENT-H&N fffffff. ENT PACK ggggggg. SPRINGS HEAD AND NECK PACK hhhhhhh. ENDO SINUS PACK iiiiiii. HEAD/NECK PACK jjjjjjj. ENT/SINUS PACK-LF kkkkkkk. ENT PACK lllllll. NASAL PACK mmmmmmm. ENT PACK nnnnnnn. ORAL PLASTIC FACIAL PACK ooooooo. ENT HEAD NECK PACK ppppppp. THYROIDECTOMY PACK qqqqqqq. MINOR ORL PACK rrrrrrr. EAR CUSTOM PACK sssssss. MG NS ENT PACK ttttttt. HEAD AND NECK PACK uuuuuuu. ENT PACK vvvvvvv. MAJOR ENT PACK wwwwwww. ENT xxxxxxx. NASAL EAR yyyyyyy. NASAL-LF zzzzzzz. LARGE ENT aaaaaaaa. EAR bbbbbbbb. HEAD AND NECK cccccccc. PAD ENT HEAD & NECK dddddddd. FHT CVOR TAVR eeeeeeee. MODULE NASAL NATALIE ffffffff. ENT-LF gggggggg. HEA

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OGR·November 17, 2022