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 28 of 1187
FDA device recalls, page 28 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1928-2026Class IILSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717HLSL HealthcareOXQ
Z-1945-2026Class IIBrand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery...Clinical Innovations, LLCHDB
Z-1825-2026Class IIPhilips Spectral CT on Rails. Model Number: 728334.Philips North America LLCJAK
Z-1807-2026Class IIThe product is a handheld ultraviolet-C germicidal wand and contains two low-pressure...Uvlizer c/o RAIS INTERNATIONAL LLCRHP
Z-1808-2026Class IIThe product is a handheld ultraviolet-C germicidal wand and contains a combination of...Uvlizer c/o RAIS INTERNATIONAL LLCRHP
Z-1828-2026Class IICUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator...Integra LifeSciences CorporationLFL
Z-2744-2026Class IIPhotera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersThe Daavlin Distributing Co.FTC
Z-2743-2026Class IIPhotera 600, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersThe Daavlin Distributing Co.FTC
Z-2742-2026Class IIPhotera 400, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersThe Daavlin Distributing Co.FTC
Z-1692-2026Class IIVue Motion V12. Product Number: 1017979.Philips Medical Systems Nederland B.V.LLZ
Z-1769-2026Class IITornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No...TORNIER Inc.KWS
Z-1792-2026Class IICOOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number...Cook IncorporatedJOL
Z-1791-2026Class IICOOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order...Cook IncorporatedJOL
Z-1790-2026Class IICOOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order...Cook IncorporatedGBX
Z-1789-2026Class IICOOK MEDICAL Spectrum Central Venous Tray: Reference Part Number...Cook IncorporatedFOZ
Z-1788-2026Class IICOOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number...Cook IncorporatedFOZ
Z-1787-2026Class IICOOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3...Cook IncorporatedLQR
Z-1786-2026Class IICOOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number...Cook IncorporatedFGE
Z-1785-2026Class IIMelker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number...Cook IncorporatedBWC
Z-1784-2026Class IICOOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number...Cook IncorporatedLQR
Z-1783-2026Class IICOOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number...Cook IncorporatedFOZ
Z-1782-2026Class IICOOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order...Cook IncorporatedJOH
Z-1781-2026Class IICOOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part...Cook IncorporatedJOH
Z-1780-2026Class IICOOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference...Cook IncorporatedJOH
Z-1779-2026Class IICOOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference...Cook IncorporatedJOH
Z-1778-2026Class IICOOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5...Cook IncorporatedDQO
Z-1777-2026Class IICOOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G...Cook IncorporatedDQX
Z-1776-2026Class IICOOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G...Cook IncorporatedDQX
Z-1775-2026Class IICOOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order...Cook IncorporatedDQX
Z-1631-2026Class IIBrand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal...Koven Technology, Inc.DPW
Z-1766-2026Class IIOXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification...Oxoid Australia Pty LimitedLQL
Z-1812-2026Class IIInstinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EOWilson-Cook Medical Inc.PKL
Z-1875-2026Class IIAccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X...Boston Scientific CorporationDQO
Z-1874-2026Class IIAccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F...Boston Scientific CorporationDQO
Z-1873-2026Class IIAccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU...Boston Scientific CorporationDQO
Z-1872-2026Class IIAccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F...Boston Scientific CorporationDQO
Z-1871-2026Class IISoft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB...Boston Scientific CorporationDQO
Z-1870-2026Class IISoft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB...Boston Scientific CorporationDQO
Z-1869-2026Class IISoft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035...Boston Scientific CorporationDQO
Z-1868-2026Class IISoft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB...Boston Scientific CorporationDQO
Z-1867-2026Class IISoft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM...Boston Scientific CorporationDQO
Z-1866-2026Class IISoft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB...Boston Scientific CorporationDQO
Z-1865-2026Class IISoft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB...Boston Scientific CorporationDQO
Z-1864-2026Class IISoft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB...Boston Scientific CorporationDQO
Z-1863-2026Class IISoft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB...Boston Scientific CorporationDQO
Z-1862-2026Class IISoft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB...Boston Scientific CorporationDQO
Z-1861-2026Class IISoft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB...Boston Scientific CorporationDQO
Z-1860-2026Class IISoft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB...Boston Scientific CorporationDQO
Z-1859-2026Class IISoft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB...Boston Scientific CorporationDQO
Z-1858-2026Class IISoft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB...Boston Scientific CorporationDQO