46 results · 22ms · Sources: EU EUDAMED, US FDA

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HENRY SCHEIN, OMFS, Item No.570-2779,

FDA Recall
Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code OFX·November 2, 2022

Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF108 6) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF109 7) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10V 8) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10W 9) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Y 10) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Z 11) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF111 12) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF112 13) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCP2 14) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP3 15) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP4 16) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPA 17) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPB 18) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPC 19) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPD 20) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPE 21) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPF

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code OFX·November 8, 2024

Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·June 27, 2024

STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray

FDA Recall
Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code OFX·November 2, 2022

Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL

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

Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003

FDA Recall
Open, Classified ·Product code OFX·January 7, 2026

Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number DYNJ17477G ; 6) ORAL SURGERY PACK-LF, Pack Number DYNJ20491N ; 7) DENTAL PACK-LF, Pack Number DYNJ36724C ; 8) DENTAL PACK WRM-LF, Pack Number DYNJ41963C ; 9) DENTAL SURGICOUNT , Pack Number DYNJ45540D ; 10) DENTAL PACK , Pack Number DYNJ49021F ; 11) DENTAL PACK , Pack Number DYNJ49021G ; 12) EXTRACTION PACK , Pack Number DYNJ49329F ; 13) CSC-N ORAL SURGERY PACK , Pack Number DYNJ50873B ; 14) ORAL SURGERY PACK , Pack Number DYNJ52404D ; 15) ORAL SURGERY PACK , Pack Number DYNJ52404F ; 16) ORAL SURGERY PACK , Pack Number DYNJ52404G ; 17) ORAL SURGERY PK RFID, Pack Number DYNJ52404I ; 18) WCMC PEDS DENTAL PACK , Pack Number DYNJ56307A ; 19) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157A ; 20) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157B ; 21) SURGERY KIT , Pack Number DYNJ58158A ; 22) SURGERY KIT , Pack Number DYNJ58158B ; 23) ORL PACK, Pack Number DYNJ59073B ; 24) ORAL SURGERY, Pack Number DYNJ59941B ; 25) ORAL SURGERY, Pack Number DYNJ59941BH; 26) MINOR DENTAL PACK-LF, Pack Number DYNJ61727I ; 27) MINOR DENTAL PACK-LF, Pack Number DYNJ61727J ; 28) MINOR DENTAL PACK-LF, Pack Number DYNJ61727K ; 29) MINOR DENTAL PACK-LF, Pack Number DYNJ61727L ; 30) DENTAL PACK , Pack Number DYNJ62779D ; 31) DENTAL PACK , Pack Number DYNJ62779F ; 32) DENTAL PACK , Pack Number DYNJ62779G ; 33) ORAL SURGERY PACK , Pack Number DYNJ66450B ; 34) ORAL PACK NTX , Pack Number DYNJ68506C ; 35) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226A ; 36) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226B ; 37) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226C ; 38) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226D ; 39) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226DH; 40) DENTAL PACK , Pack Number DYNJ80375; 41) ORAL SURGERY PACK , Pack Number DYNJ80619; 42) ORAL SURGERY PACK , Pack Number DYNJ80619A ; 43) DEAN DENTAL PACK, Pack Number DYNJ80644; 44) DEAN DENTAL PACK, Pack Number DYNJ80644A ; 45) DENTAL MINOR PACK , Pack Number DYNJ83140; 46) DENTAL PACK , Pack Number DYNJ84533; 47) ORAL SURGERY PACK-LF, Pack Number DYNJ84849; 48) ORAL, Pack Number DYNJ902377G; 49) ORAL SURGERY PACK-LF, Pack Number DYNJ904595D; 50) NYGH-MAJOR DENTAL-LF, Pack Number DYNJ905540F; 51) NYGH-MINOR DENTAL-PLASTIC-LF, Pack Number DYNJ905551C; 52) NORTH DENTAL, Pack Number DYNJ906941B; 53) ORAL, Pack Number DYNJ908371 ; 54) ORAL, Pack Number DYNJ908371A; 55) ORAL, Pack Number DYNJ908371B; 56) ORAL, Pack Number DYNJ908371C; 57) DENTAL, Pack Number DYNJ909635 ; 58) DENTAL, Pack Number DYNJ909635A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·April 8, 2024

Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·March 22, 2024

MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·October 9, 2024

Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code OFX·November 8, 2024

Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841C; 6) NYGH-MINOR DENTAL-PLASTIC-LF, Model Number: DYNJ905551C

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·March 3, 2025

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·May 15, 2023

Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·September 4, 2024

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.

FDA Recall
Open, Classified ·Product code OFX·March 19, 2026

MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A

FDA Recall
Open, Classified ·Product code OFX·May 4, 2026

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·May 18, 2023

Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK

FDA Recall
Open, Classified ·Product code OFX·January 7, 2026

Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·February 23, 2024

Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·February 23, 2024

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·December 8, 2025