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

59,336 records, page 25 of 1187
FDA device recalls, page 25 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1902-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.OLYMPUS Corporation of the AmericasFEB
Z-1901-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.OLYMPUS Corporation of the AmericasFEB
Z-1900-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112OLYMPUS Corporation of the AmericasFEB
Z-1899-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111OLYMPUS Corporation of the AmericasFEB
Z-1898-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be...OLYMPUS Corporation of the AmericasFEB
Z-2399-2026Class IIHintermann Series Talar Implant, Left, Size 2 REF 302112DT MedTech, LLCNTG
Z-2148-2026Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2147-2026Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: 1...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2146-2026Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2145-2026Class I1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2144-2026Class I1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2143-2026Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-2142-2026Class INamic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular...MEDLINE INDUSTRIES, LP - NorthfieldDRS
Z-2141-2026Class INamic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular...MEDLINE INDUSTRIES, LP - NorthfieldDRS
Z-2140-2026Class INamic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary...MEDLINE INDUSTRIES, LP - NorthfieldDTL
Z-2139-2026Class INamic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary...MEDLINE INDUSTRIES, LP - NorthfieldDTL
Z-2138-2026Class INamic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary...MEDLINE INDUSTRIES, LP - NorthfieldDTL
Z-1937-2026Class IIProtocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within...Foundation Medicine, Inc.PQP
Z-2210-2026Class IIOncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp...Abbott MedicalONB
Z-1806-2026Class IIYeastone Broth, 11ML, 10/BOX YY3462Remel IncNGZ
Z-2855-2026Class IINerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0...Theranica Bio-Electronics Ltd.QGT
Z-1950-2026Class IIBrand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery...Advanced Bionics LLCMCM
Z-2209-2026Class IITangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND...Tangent Endoscopy, LLCFBN
Z-1823-2026Class IIGentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;Gentuity, LLCDQO
Z-1854-2026Class IIOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.OLYMPUS Corporation of the AmericasGEI
Z-1853-2026Class IIOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.OLYMPUS Corporation of the AmericasGEI
Z-1852-2026Class IIOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.OLYMPUS Corporation of the AmericasGEI
Z-1851-2026Class IIOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.OLYMPUS Corporation of the AmericasGEI
Z-1949-2026Class IIBrand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco...Hologic, Inc.QYV
Z-2051-2026Class IIProdisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc...Centinel Spine, LLCMJO
Z-2050-2026Class IIProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.Centinel Spine, LLCMJO
Z-1927-2026Class IISequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)Foundation Medicine, Inc.PQP
Z-2898-2026Class IIBrand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and...United Orthopedic Corp.LXH
Z-2897-2026Class IIBrand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and...United Orthopedic Corp.LWH
Z-1981-2026Class IConvenience kits containing Medline Namic Angiographic Control Syringes with Rotating...American Contract Systems, Inc.LRO
Z-2038-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges (4077 in total)...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2037-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-2036-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-2035-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-2034-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2033-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2032-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldHBA
Z-2031-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldFMH
Z-2030-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldPKD
Z-2029-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-2028-2026Class IICenturion medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-2027-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges (1050 in total)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2026-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-2025-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges (102 in total)MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-2024-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldPPB