510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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

59,460 records, page 92 of 1190
FDA device recalls, page 92 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1382-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF...Oridion Medical 1987 Ltd.CCK
Z-1381-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF...Oridion Medical 1987 Ltd.CCK
Z-1380-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF...Oridion Medical 1987 Ltd.CCK
Z-1379-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF...Oridion Medical 1987 Ltd.CCK
Z-1378-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF...Oridion Medical 1987 Ltd.CCK
Z-1377-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF...Oridion Medical 1987 Ltd.CCK
Z-1376-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF...Oridion Medical 1987 Ltd.CCK
Z-1397-2025Class IIIntrocan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV...B Braun Medical IncFOZ
Z-1557-2025Class IIAveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code...Abbott MedicalPNJ
Z-1374-2025Class IIModular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product...Waldemar Link GmbH & Co. KGJWH
Z-1373-2025Class IIModular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product...Waldemar Link GmbH & Co. KGJWH
Z-1372-2025Class IIModular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product...Waldemar Link GmbH & Co. KGJWH
Z-1405-2025Class IICAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214Abbott MedicalCCK
Z-1404-2025Class IICAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100Abbott MedicalCCK
Z-1370-2025Class IIProxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1369-2025Class IIProxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-1368-2025Class IIProxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1367-2025Class IIProxima Drape labeled as FACE LIFT. Sterile surgical drape.MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1366-2025Class IIProxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1365-2025Class IIProxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1364-2025Class IIProxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1363-2025Class IIProxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS...MEDLINE INDUSTRIES, LP - NorthfieldPUI
Z-1201-2025Class IIremel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic useRemel IncJSI
Z-1200-2025Class IIremel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic useRemel IncJSI
Z-1288-2025Class Ismiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm...Abbott MedicalLJT
Z-1287-2025Class Ismiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane...Abbott MedicalLJT
Z-1286-2025Class Ismiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems...Abbott MedicalLJT
Z-1285-2025Class Ismiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow...Abbott MedicalLJT
Z-1284-2025Class Ismiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow...Abbott MedicalLJT
Z-1283-2025Class Ismiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D...Abbott MedicalLJT
Z-1282-2025Class Ismiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow...Abbott MedicalLJT
Z-1281-2025Class Ismiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter...Abbott MedicalLJT
Z-1280-2025Class Ismiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter...Abbott MedicalLJT
Z-1279-2025Class Ismiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter...Abbott MedicalLJT
Z-1278-2025Class Ismiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr)...Abbott MedicalLJT
Z-1277-2025Class Ismiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D...Abbott MedicalLJT
Z-1289-2025Class IPortex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020...Abbott MedicalBTR
Z-1323-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software...ZOLL Medical CorporationMKJ
Z-1322-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO...ZOLL Medical CorporationMKJ
Z-1321-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software...ZOLL Medical CorporationMKJ
Z-1320-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2)...ZOLL Medical CorporationMKJ
Z-1319-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2)...ZOLL Medical CorporationMKJ
Z-1318-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2)...ZOLL Medical CorporationMKJ
Z-1317-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2)...ZOLL Medical CorporationMKJ
Z-1316-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2)...ZOLL Medical CorporationMKJ
Z-2478-2026Class IIMito Red Light, Super MobileMito Red Light LLCILY
Z-1431-2025Class IInamic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1430-2025Class IInamic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-1429-2025Class IInamic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit...MEDLINE INDUSTRIES, LP - NorthfieldDRS
Z-1428-2025Class IInamic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical...MEDLINE INDUSTRIES, LP - NorthfieldDRI