510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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

59,544 records, page 656 of 1191
FDA device recalls, page 656 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1404-2015Class IIPluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx...Teleflex MedicalKDQ
Z-1335-2015Class IEbola Virus GP-VP IgS, Catalog No. I-124 virus test kitLusys Laboratories, Inc.N/A
Z-1334-2015Class IEbola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in...Lusys Laboratories, Inc.N/A
Z-1333-2015Class IEbola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in...Lusys Laboratories, Inc.N/A
Z-1332-2015Class IEbola Accessories assembled, self-contained package, Catalog No. I-104 virus test kitLusys Laboratories, Inc.N/A
Z-1331-2015Class IEbola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kitLusys Laboratories, Inc.N/A
Z-1330-2015Class IEbola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials...Lusys Laboratories, Inc.N/A
Z-1329-2015Class IEbola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1...Lusys Laboratories, Inc.N/A
Z-1328-2015Class IEbola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1...Lusys Laboratories, Inc.N/A
Z-1825-2015Class IIGE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood...GE HealthcareIOL
Z-2152-2015Class IIPolaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw...Highridge Medical, LLCNKB
Z-1675-2015Class IIPanorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia...Datascope Corp.MHX
Z-1466-2015Class IITorque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides...Highridge Medical, LLCHXC
Z-1465-2015Class IILineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed...Highridge Medical, LLCHXC
Z-1311-2015Class IIAlaris PC units, Model No. 8015. Infusion pump.CareFusion 303, IncFRN
Z-1908-2016Class IABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection...Hummingbird MedKST
Z-1682-2015Class IIIngenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI)...Philips North America LLCKPS
Z-1607-2015Class IINuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO...Philips North America LLCLMC
Z-1512-2015Class IIXpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for...Xtant Medical Holdings, Inc.MNH
Z-1394-2015Class IIINFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac...Canon Medical Systems USA, Inc.OWB
Z-1453-2015Class IITalon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies...United States Endoscopy Group, Inc.OCZ
Z-1349-2015Class IIINTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The...Microtek Medical LLCFYD
Z-1348-2015Class IILASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA...Microtek Medical LLCFYD
Z-1347-2015Class II(S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF...Microtek Medical LLCFYD
Z-1346-2015Class IITUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO...Microtek Medical LLCFYD
Z-1345-2015Class IIVACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010...Microtek Medical LLCFYD
Z-1344-2015Class IIVACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended...Microtek Medical LLCFYD
Z-1343-2015Class IITUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use...Microtek Medical LLCFYD
Z-1342-2015Class IISmoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88...Microtek Medical LLCFYD
Z-1341-2015Class IILAPAROSCOPIC TUBING SET, 3/16" X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE...Microtek Medical LLCFYD
Z-1340-2015Class IIFREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO...Microtek Medical LLCFYA
Z-1339-2015Class IIFREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO...Microtek Medical LLCFYA
Z-1338-2015Class IIFREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical...Microtek Medical LLCFYA
Z-1337-2015Class IIFREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE...Microtek Medical LLCFYA
Z-1521-2015Class IISoftware Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375...Ortho-Clinical Diagnostics, Inc.JJE
Z-1360-2015Class IIBrand Name: Persona Anterior Referencing Sizer with Locking Boom The Persona Anterior...Zimmer GmbHJWH
Z-3129-2017Class IIFujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This...FUJIFILM Healthcare Americas CorporationFDT
Z-3128-2017Class IIFujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope...FUJIFILM Healthcare Americas CorporationFDT
Z-1440-2015Class IINobelReplace CC PMC RP 5.0x13mm, Article No. 37298.Nobel Biocare USA LLCDZE
Z-1439-2015Class IINobelReplace CC PMC RP 5.0x10mm, Article No. 37296.Nobel Biocare USA LLCDZE
Z-1438-2015Class IINobelReplace CC PMC RP 4.3x10mm, Article No. 37291.Nobel Biocare USA LLCDZE
Z-1437-2015Class IINobelReplace CC PMC RP 4.3x8mm, Article No. 37290.Nobel Biocare USA LLCDZE
Z-1436-2015Class IINobelReplace CC PMC NP 3.5x13mm, Article No. 37288.Nobel Biocare USA LLCDZE
Z-1435-2015Class IINobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.Nobel Biocare USA LLCDZE
Z-1434-2015Class IINobelReplace CC RP 5.0x13mm, Article No. 36713.Nobel Biocare USA LLCDZE
Z-1433-2015Class IINobelReplace CC RP 5.0x10mm, Article No. 36711.Nobel Biocare USA LLCDZE
Z-1432-2015Class IINobelReplace CC RP 5.0x8mm, Article No. 36710.Nobel Biocare USA LLCDZE
Z-1431-2015Class IINobelReplace CC RP 4.3x13mm, Article No. 36708.Nobel Biocare USA LLCDZE
Z-1430-2015Class IINobelReplace CC RP 4.3x11.5mm, Article No. 36707.Nobel Biocare USA LLCDZE
Z-1429-2015Class IINobelReplace CC RP 4.3x10mm, Article No. 36705.Nobel Biocare USA LLCDZE