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Sources: EU EUDAMED, US FDA
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Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
FDA Recall
Open, Classified
·Product code LXH·February 4, 2019
4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913 e) M-FAK Mini First Aid Kit; Kit Product Code: 80-0914 f) Trauma and First Aid Kit; Kit Product Code: 80-0947 g) Trauma and First Aid Kit; Kit Product Code: 80-0948 h) Trauma and First Aid Kit; Kit Product Code: 80-1047 i) Trauma and First Aid Kit Hard Case, Class B, with Bleeding Control Dressing; Kit Product Code: 80-1048 j) Micro individual first aid kit; Kit Product Code: 82-0002 k) Individual Aid Kit; Kit Product Code: 85-0404 l) KMBR HII Kit; Kit Product Code: 85-0757 m) Compact Officer Response Emergency Kit; Kit Product Code: 85-0834 n) Public Access Bleeding Control Twin Pack, Basic; Kit Product Code: 80-0951 o) Public Access Bleeding Control Twin Pack, Intermediate; Kit Product Code: 80-0952 p) Public Access Bleeding Control Twin Pack, Advanced BCD; Kit Product Code: 80-0953 q) Trauma and First Aid Kit; Kit Product Code: 80-1033 r) Trauma and First Aid Kit Hard Case; Kit Product Code: 80-1034 s) Tactical Quick Reaction Individual first aid kit; Kit Product Code: 85-1128 t) M-FAK Kit with S-Rolled Gauze; Kit Product Code: 85-1502 u) Public access individual bleeding control kit; Kit Product Code: 85-1574 v) Emergency Trauma Bleeding control pack; Kit Product Code: 85-1583 w) Bleeding control Kit; Kit Product Code: 85-1759 x) TORK Kit; Kit Product Code: 85-1907 y) Black scout survival IFAK individual first aid kit; Kit Product Code: 85-1942 z) Texas water first aid kit; Kit Product Code: 85-1953 aa) Crisis Ki; Kit Product Code: 85-1970 ab) ALE IFAK individual first aid kit; Kit Product Code: 85-2150 ac) RACH regional advisory council hemorrhage kit; Kit Product Code: 85-2176 ad) Triad Medical's SRAK student response aid kit; Kit Product Code: 85-2327 ae) ODIN medical EMT kit; Kit Product Code: 85-2425 af) ODIN medical AEMT kit; Kit Product Code: 85-2426 ag) Henry Schein public access individual bleeding control kit; Kit Product Code: 85-2430 ah) Henry Schein public access individual bleeding control kit; Kit Product Code: 85-2432 ai) Warrior Poet society Public access individual bleeding control kit; Kit Product Code: 85-2539 aj) Spec Train Compact Carry kit; Kit Product Code: 85-2833 ak) Belfast FD resupply kit; Kit Product Code: 85-2886 al) Trauma and First Aid Kit; Kit Product Code: 80-1045 am) Trauma and First Aid Kit Hard Case Class A, with Bleeding Control Dressing; Kit Product Code: 80-1046 an) M-FAK Kit; Kit Product Code: 85-2920 ao) IFAK individual first aid kit; Kit Product Code: 85-3022 ap) Bleeding control kit; Kit Product Code: 85-3046 aq) Individual first aid kit allegiance holster company; Kit Product Code: 85-3050 ar) RAC-PAK; Kit Product Code: 85-3052 as) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3067 at) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3068 au) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3069 av) Task Force 6 resupply kit; Kit Product Code: 85-3078 aw) PABC Kit; Kit Product Code: 85-3082 ax) MCC IFAK Small Supply Kit; Kit Product Code: 85-3084 ay) MCC IFAK Large Supply Kit; Kit Product Code: 85-3085
FDA Recall
Terminated
·North American Rescue LLC.·Product code FQM·August 21, 2020
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
FDA Recall
Terminated
·Arrow International Inc·Product code MPB·October 17, 2017
LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
BostonSight SCLERAL Lens
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
BostonSight PROSE Lens.
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF DYNJ63165B; g) BIOPSY TRAY FOAKS, REF DYNJ63575A; h) CUSTOM SOFT TISSUE PACK, REF DYNJ66347A; i) KWIK PACK, REF DYNJ67926B; j) ESI TRAY, REF DYNJ68261B; k) LARGE BIOPSY PACK NTX, REF DYNJ68393A; l) LOOP KIT, REF DYNJ84129
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OFG·September 4, 2024
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
FDA Recall
Terminated
·Centers For Disease Control and Prevention·Product code OZE·April 26, 2024
Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP A PACK, Pack Number DYNJ40647G; 7) IPMC BREAST PACK-LF, Pack Number DYNJ0665560D; 8) OCULAR PLASTICS PACK, Pack Number DYNJ40356A; 9) OCULOPLASTY PACK-LF, Pack Number DYNJ0252232U; 10) PACK MASTECTOMY COMBO CHRG, Pack Number DYNJ60232A; 11) PLASTIC GENERAL SURGERY - OSC, Pack Number DYNJ43576A; 12) PLASTIC PACK, Pack Number DYNJ00264L; 13) PLASTIC PACK, Pack Number DYNJ49742B; 14) PLASTIC PK II, Pack Number DYNJ14039B; 15) PLASTIC-GENERAL SURGERY PACK, Pack Number DYNJ09866U; 16) PLASTICS FACIAL PACK ST MARY, Pack Number DYNJ45861B; 17) PLASTICS PACK, Pack Number DYNJ68288A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FTN·February 11, 2025
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·April 22, 2024