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 341 of 1190
FDA device recalls, page 341 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2743-2020Class IIRemisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data...Normand-Info S.A.S.U.JQP
Z-2289-2020Class IIElekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage...Elekta LimitedIYE
Z-2302-2020Class IIMulti Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System)...Siemens Medical Solutions USA, Inc.OWB
Z-1994-2020Class IIDover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18...Medtronic, Inc.KOD
Z-1993-2020Class IIDover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch...Medtronic, Inc.KOD
Z-1992-2020Class IIDover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16...Medtronic, Inc.KOD
Z-1991-2020Class IIDover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium...Medtronic, Inc.KOD
Z-1990-2020Class IIDover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL...Medtronic, Inc.KOD
Z-1989-2020Class IIDover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley...Medtronic, Inc.KOD
Z-1988-2020Class IIDover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL...Medtronic, Inc.KOD
Z-1987-2020Class IIDover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR...Medtronic, Inc.KOD
Z-1986-2020Class IIDover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T...Medtronic, Inc.KOD
Z-1985-2020Class IIDover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR...Medtronic, Inc.KOD
Z-1984-2020Class IIDover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code...Medtronic, Inc.KOD
Z-2246-2020Class IICentrella Smart+ Bed, Catalog Number P7900Hill-Rom Inc.FNL
Z-2204-2020Class IIPressure Monitoring Tray, C-PMSY, G02854Cook IncorporatedDQY
Z-2203-2020Class IIPressure Monitoring Set, C-PMS, G02838Cook IncorporatedDQY
Z-2126-2020Class IISamco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number...Thermo Fisher Scientific (Monterrey)FMH
Z-2236-2020Class IIGiraffe Incubator with installed Servo Oxygen module. Infant incubator.GE HealthcareFMZ
Z-2235-2020Class IIGiraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.GE HealthcareFMZ
Z-2394-2020Class IIDDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E...Defibtech LLCMKJ
Z-2393-2020Class IIDDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External...Defibtech LLCMKJ
Z-2392-2020Class IIDDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN...Defibtech LLCMKJ
Z-2157-2020Class IIPhilips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M...Philips North America LLCMKJ
Z-2109-2020Class IISkater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000...Argon Medical Devices, IncGCB
Z-0073-2022Class IIAngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation...Boston Scientific CorporationOAB
Z-2360-2020Class IIInfant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced...Physio Control, Inc.MKJ
Z-2464-2020Class IIVein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert...LivaNova USA, Inc.DWF
Z-2463-2020Class IIVein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert...LivaNova USA, Inc.DWF
Z-2462-2020Class II1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322LivaNova USA, Inc.DTL
Z-2461-2020Class II1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315LivaNova USA, Inc.DTL
Z-2460-2020Class II3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292LivaNova USA, Inc.DTL
Z-2459-2020Class II3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285LivaNova USA, Inc.DTL
Z-2458-2020Class II1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278LivaNova USA, Inc.DTL
Z-2457-2020Class IISterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2456-2020Class IISterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2455-2020Class IISterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2454-2020Class IISterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2453-2020Class IISterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2452-2020Class IISterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2451-2020Class IISterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2450-2020Class IISterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2449-2020Class IISterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2448-2020Class IISterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2447-2020Class IISterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2446-2020Class IISterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2445-2020Class IISterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2444-2020Class IISterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2443-2020Class IISterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert...LivaNova USA, Inc.DTL
Z-2391-2020Class IIMedtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and...Medtronic Sofamor Danek USA IncHRX