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 796 of 1190
FDA device recalls, page 796 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2030-2012Class IIISIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A...Baxter Healthcare CorporationFRN
Z-1505-2012DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable...O'Ryan Industries IncEBZ
Z-0094-2013Class IIOptimum Expanse S Multiple sizes Grafton is a human bone allograft product containing...Osteotech IncMBP
Z-0093-2013Class IIOptimum Expanse R Grafton is a human bone allograft product containing demineralized...Osteotech IncMBP
Z-0092-2013Class IIGrafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft...Osteotech IncMBP
Z-0091-2013Class IIGrafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft...Osteotech IncMBP
Z-0090-2013Class IIGrafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft...Osteotech IncMBP
Z-0089-2013Class IIGrafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product...Osteotech IncMBP
Z-0088-2013Class IIGrafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product...Osteotech IncMBP
Z-0087-2013Class IIGrafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing...Osteotech IncMBP
Z-0086-2013Class IIGrafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing...Osteotech IncMBP
Z-0085-2013Class IIGrafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing...Osteotech IncMBP
Z-0084-2013Class IIGrafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing...Osteotech IncMBP
Z-0083-2013Class IIGrafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing...Osteotech IncMBP
Z-0100-2018Class IIROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled...Zimmer GmbHHAW
Z-0454-2014Class IIThe GE Centricity Web; Software Version 3.0x, is intended for use under the direct...GE HealthcareLMD
Z-1651-2012MLCi/MCLi2. Radiation therapy.Elekta LimitedIYE
Z-0800-2013Class IIBacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID#...Xtant Medical Holdings, Inc.MBP
Z-0605-2013Class IIMedrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed...Medrad, Inc.FPA
Z-0604-2013Class IIMedrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System...Medrad, Inc.FPA
Z-0603-2013Class IIMedrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System...Medrad, Inc.FPA
Z-0602-2013Class IIMedrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed...Medrad, Inc.FPA
Z-0601-2013Class IIMedrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System...Medrad, Inc.FPA
Z-0600-2013Class IIMedrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed...Medrad, Inc.FPA
Z-0599-2013Class IIMedrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System...Medrad, Inc.FPA
Z-0598-2013Class IIMedrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for...Medrad, Inc.FPA
Z-0597-2013Class IIMedrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump...Medrad, Inc.FPA
Z-0596-2013Class IIMedrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump...Medrad, Inc.FPA
Z-0595-2013Class IIMedrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who...Medrad, Inc.FRN
Z-1521-2012Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single...Zimmer GmbHJXE
Z-1628-2012Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange...Arcadia Medical CorporationBTO
Z-2131-2012Class IIFlush Kit w 3 Way Off Stopcock Product Usage: Flush KitAbbott MedicalDQO
Z-2130-2012Class II94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer...Abbott MedicalFMG
Z-2129-2012Class IICardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin...Abbott MedicalDQO
Z-2128-2012Class IIHigh Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.Abbott MedicalDQO
Z-1536-2012LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item...GF Health Products, Inc.LLI
Z-0634-2014Class IITracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight...Invacare GmbHIOR
Z-2168-2013Class IIOPERON D850 Surgical Table Product Usage: Surgical TableBerchtold Corp.GDC
Z-1480-2012Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion...Vygon MfgFMI
Z-1477-2012EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical...Omarc LLCKPJ
Z-1335-2012U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small...Milabs BVRFK
Z-2108-2012Class IIMaquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version...Maquet Cardiovascular Us Sales, LLCFQO
Z-1646-2012Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a...Philips North America LLCOUO
Z-1772-20126.0 MM DIAMETER 50 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF...Smith & Nephew, Inc.JDW
Z-1771-20126.0 MM DIAMETER 40 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF...Smith & Nephew, Inc.JDW
Z-1770-20126.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF...Smith & Nephew, Inc.JDW
Z-1769-20126.0 MM DIAMETER 30 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF...Smith & Nephew, Inc.JDW
Z-1768-20126.0 MM DIAMETER 25 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF...Smith & Nephew, Inc.JDW
Z-1767-20125.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF...Smith & Nephew, Inc.JDW
Z-1766-2012JET-X(R) 5 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71055701, QTY: (1), STERILE R, Smith...Smith & Nephew, Inc.JDW