510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,336 records, page 17 of 1187
FDA device recalls, page 17 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2496-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-2495-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-2494-2026Class IIMEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU...MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-2493-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-2492-2026Class IIMEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit...MEDLINE INDUSTRIES, LP - NorthfieldEYB
Z-2491-2026Class IIMEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2490-2026Class IIMEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit...MEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-2489-2026Class IIMEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-2488-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-2487-2026Class IIMEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2486-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2485-2026Class IIMEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-2484-2026Class IIMEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL...MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-2483-2026Class IIMEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL...MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-2482-2026Class IIMEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product...MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-2481-2026Class IIMEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr...MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-2480-2026Class IIMEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU...MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-2479-2026Class IIMEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French...MEDLINE INDUSTRIES, LP - NorthfieldEYB
Z-2353-2026Class IISD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software...MicroMed, LLCGWQ
Z-2212-2026Class IPediatric care bed; Product Designation: KayserBett IDA;Kayserbetten GmbH & Co. KGFNL
Z-2477-2026Class IIGiraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and...GE HealthcareFMZ
Z-2476-2026Class IIGiraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an...GE HealthcareFMZ
Z-2475-2026Class IIGiraffe OmniBed, a combination of an infant incubator and an infant warmer, All ModelsGE HealthcareFMZ
Z-2354-2026Class IIDigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.Philips North America LLCMQB
Z-2330-2026Class IICGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040INSPIREMD IncNIM
Z-2329-2026Class IICGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030INSPIREMD IncNIM
Z-2328-2026Class IIBrand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number...INSPIREMD IncNIM
Z-2327-2026Class IICGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930INSPIREMD IncNIM
Z-2326-2026Class IIBrand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number...INSPIREMD IncNIM
Z-2325-2026Class IIBrand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number...INSPIREMD IncNIM
Z-2798-2026Class IHalyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle...Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-2797-2026Class IHalyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle...Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-2796-2026Class IHalyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle...Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-2410-2026Class IIHalyard, Eye Bag Pack. Kit Code: UIEB48-01.Avid Medical, Inc. a Medical Action Ind. Company 305OJH
Z-2409-2026Class IIHalyard, Drape Pack. Kit Code: LMDP36-01.Avid Medical, Inc. a Medical Action Ind. Company 305OJH
Z-2408-2026Class IIHalyard, Towel Six Pack. Kit Code: AMTS70-01.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2407-2026Class IIHalyard, Pain Pack. Kit Code: AMPK48-01.Avid Medical, Inc. a Medical Action Ind. Company 305OJH
Z-2460-2026Class IIdirectCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2Accriva Diagnostics, Inc.GGN
Z-2618-2026Class IIShort Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972...Medacta USA, Inc.PHX
Z-2573-2026Class IISurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines...Surgify Medical OyHBE
Z-2572-2026Class IISurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines...Surgify Medical OyHBE
Z-2571-2026Class IISurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines...Surgify Medical OyHBE
Z-2570-2026Class IISurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines...Surgify Medical OyHBE
Z-2569-2026Class IISurgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs...Surgify Medical OyHBE
Z-2568-2026Class IISurgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines &...Surgify Medical OyHBE
Z-2567-2026Class IISurgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs...Surgify Medical OyHBE
Z-2566-2026Class IISurgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs...Surgify Medical OyHBE
Z-2565-2026Class IISurgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs...Surgify Medical OyHBE
Z-2564-2026Class IISurgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs...Surgify Medical OyHBE
Z-2563-2026Class IISurgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines...Surgify Medical OyHBE