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

59,460 records, page 1092 of 1190
FDA device recalls, page 1092 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0786-06Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is...Remel IncKTN
Z-0574-06Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.Roche Diagnostics GmbHLFW
Z-0573-06Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001...Roche Diagnostics GmbHLFR
Z-0572-06Accu-Chek Sensor Comfort Pro blood glucose test strips; Reference numbers 0375877001...Roche Diagnostics GmbHLFR
Z-0571-06Accu-Chek Sensor Comfort blood glucose test strips; Reference numbers 03261956170...Roche Diagnostics GmbHLFR
Z-0570-06Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold...Roche Diagnostics GmbHLFR
Z-0569-06Accu-Chek Advantage Plus blood glucose test strips; Reference number 04735102001 (All...Roche Diagnostics GmbHLFR
Z-0568-06Accu-Chek Advantage II blood glucose test strips; Reference numbers 12030659001...Roche Diagnostics GmbHLFR
Z-0567-06Accu-Chek Advantage blood glucose test strips; Reference numbers 03144917001...Roche Diagnostics GmbHLFR
Z-0566-06Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001...Roche Diagnostics GmbHLFR
Z-1234-063M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog...3M CompanyFRL
Z-0609-06Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is...Biogenex Laboratories, Inc.MVC
Z-0608-06Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is...Biogenex Laboratories, Inc.MVC
Z-0607-06Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is...Biogenex Laboratories, Inc.MVC
Z-0606-06Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is...Biogenex Laboratories, Inc.MVC
Z-0556-06Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial...Lumenis LtdGEX
Z-0599-06Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug...Baxter Healthcare CorporationFRN
Z-0612-06Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare...Baxter Healthcare CorporationFRN
Z-1995-2009Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 &...GE HealthcareMLD
Z-1994-2009Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A...GE HealthcareMLD
Z-0862-06REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR...Konica Minolta, Inc.LLZ
Z-0709-06GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin...GE HealthcareLLZ
Z-0582-06Allura Xper FD10 x-ray systemPhilips North America LLCIZI
Z-0581-06Allura Xper FD10/10 x-ray systemPhilips North America LLCIZI
Z-0586-06B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml...B Braun Medical IncKPE
Z-0583-06UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlierSiemens Healthcare Diagnostics Inc.JJE
Z-0622-06Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACSFUJIFILM Healthcare Americas CorporationLLZ
Z-0670-06Stryker PainPump1.5 2-Day Infusion Kit; Product number 501-140-000.Stryker Corp.MEA
Z-0669-06Stryker PainPump1.5 5-Day Infusion Kit; Product number 501-120-000.Stryker Corp.MEA
Z-0668-06Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000.Stryker Corp.MEA
Z-0667-06Stryker PainPump1 2-Site Y-Connector; Product number 500-250-000.Stryker Corp.MEA
Z-0666-06Stryker PainPump1 2-Site Y-Connector; Product number 500-200-000.Stryker Corp.MEA
Z-0665-06Stryker PainPump1 1-Day Infusion Kit; Product number 500-140-000.Stryker Corp.MEA
Z-0664-06Stryker PainPump1 2-Day Infusion Kit; Product number 500-120-000.Stryker Corp.MEA
Z-0663-06Stryker PainPump1 5-Day Infusion Kit ; Product number 500-110-000.Stryker Corp.MEA
Z-0662-06Stryker PainPump1 Base Kit; Product number 500-100-000.Stryker Corp.MEA
Z-0911-06Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the...Medtronic, Inc.DPS
Z-0771-06Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number 83-7712-035-02...Zimmer GmbHLXH
Z-0770-06Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01...Zimmer GmbHLXH
Z-0672-06Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees...Zimmer GmbHLXH
Z-0671-06Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees...Zimmer GmbHLXH
Z-0661-06Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeterMasimo CorporationDQA
Z-0718-06AxiEM EM Knee Kit, and associated workstation.Medtronic Navigation, IncHAW
Z-0546-06LIFEPAK 500 automated external defibrillator (AED)Physio Control, Inc.MKJ
Z-0545-06Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before...Lumenis LtdGEX
Z-0548-06LIFEPAK EXPRESS defibrillatorPhysio Control, Inc.MKJ
Z-0547-06LIFEPAK CR Plus defibrillatorPhysio Control, Inc.MKJ
Z-0512-06Roche brand Elecsys Troponin T; catalog number 2017644.Roche Diagnostics GmbHMMI
Z-0603-06Thermoplastic templates, free-end situation Catalog Number: 040.527Straumann USA, LLCDZJ
Z-0602-06Thermoplastic templates, single tooth Catalog Number: 040.526Straumann USA, LLCDZJ