510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,486 records, page 395 of 1190
FDA device recalls, page 395 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2209-2019Class IIEnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton...Bard Peripheral Vascular IncKNW
Z-2156-2019Class IISenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous...Sentec AGLKD
Z-2155-2019Class IISenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for...Sentec AGLKD
Z-2154-2019Class IISenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product...Sentec AGLKD
Z-2153-2019Class IISenTec Standard Starter Set with and without Service Gas (2 changers each) - Product...Sentec AGLKD
Z-2152-2019Class IISenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for...Sentec AGLKD
Z-1952-2019Class IIRevive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder...Rinovum Subsidiary 2, LLCHHW
Z-0049-2020Class IICareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement...Becton Dickinson & CoFPA
Z-1780-2019Class IINeff Percutaneous Access Set, Catalog Number NPAS-100-RH-NTCook IncorporatedKGZ
Z-1411-2019Class IIOAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product...Oakworks IncIXR
Z-1671-2020Class IIARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is...Abbott MedicalJJE
Z-1932-2019Class IIMedtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX...Medtronic Navigation, IncOXO
Z-2489-2019Class IB.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032B Braun Medical IncFPA
Z-1687-2019Class IIAbbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR...Abbott VascularNKM
Z-2242-2020Class IIBeckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898...Siemens Healthcare Diagnostics Inc.JNL
Z-2241-2020Class IIBeckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF...Siemens Healthcare Diagnostics Inc.NIG
Z-2240-2020Class IIBeckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI...Siemens Healthcare Diagnostics Inc.MSW
Z-2239-2020Class IIBeckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830...Siemens Healthcare Diagnostics Inc.CDP
Z-2238-2020Class IIBeckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422...Siemens Healthcare Diagnostics Inc.CDP
Z-2237-2020Class IIBeckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880...Siemens Healthcare Diagnostics Inc.CEC
Z-2052-2019Class IIMonoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389Medtronic, Inc.FMI
Z-2051-2019Class IIMonoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363Medtronic, Inc.FMI
Z-2050-2019Class IIMonoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355Medtronic, Inc.FMI
Z-2049-2019Class IIMonoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322Medtronic, Inc.FMI
Z-2048-2019Class IIMonoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314Medtronic, Inc.FMI
Z-2047-2019Class IIMonoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654Medtronic, Inc.FMI
Z-2046-2019Class IIMonoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548Medtronic, Inc.FMI
Z-2045-2019Class IIMonoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522Medtronic, Inc.FMI
Z-2044-2019Class IIMonoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498Medtronic, Inc.FMI
Z-2043-2019Class IIMonoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456Medtronic, Inc.FMI
Z-2042-2019Class IIMonoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664Medtronic, Inc.FMI
Z-2041-2019Class IIMonoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508Medtronic, Inc.FMI
Z-2040-2019Class IIMonoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078Medtronic, Inc.FMI
Z-2039-2019Class IIMonoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045Medtronic, Inc.FMI
Z-2038-2019Class IIMonoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037Medtronic, Inc.FMI
Z-2037-2019Class IIMonoject Standard Hypodermic Needle Item code: 8881200029Medtronic, Inc.FMI
Z-2036-2019Class IIMonoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011Medtronic, Inc.FMI
Z-1849-2019Class IIEndotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1Stryker Corp.HRX
Z-1848-2019Class IIEndotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1Stryker Corp.HRX
Z-2199-2019Class IIPhilips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G...Philips North America LLCIYN
Z-1772-2019Class IIIPhilips IntelliBridge System configured with a regional setting which uses a comma for a...Philips North America LLCN/A
Z-1771-2019Class IIIPhilips Patient Information Center iX configured with a regional setting which uses a...Philips North America LLCMHX
Z-1955-2019Class IIMAHURKAR and Argyle acute hemodialysis catheters, Material numbers...Medtronic, Inc.NIE
Z-1387-2019Class IIDEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a...KaVo Dental Technologies, LLCMUH
Z-1843-2019Class IIIAquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe...Cytocell LimitedMVU
Z-1844-2019Class IIZenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108...Cook IncorporatedMIH
Z-1496-2019Class IIThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b)...Angelini Pharma Inc.IMD
Z-2099-2019Class IIInovo Single Luman Conserver Product Usage: This device is intended to regulate the flow...Inovo Inc.NFB
Z-1495-2019Class IIThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage...Angelini Pharma Inc.IMD
Z-1690-2019Class IIOpteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90Exactech, Inc.MQV