510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 618 of 1191
FDA device recalls, page 618 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0495-2016Class IIIDrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup...Ameditech, Inc.JXM
Z-0494-2016Class IIIDrugSmart 11 Test Cup, Item No. 61127DAmeditech, Inc.JXM
Z-0493-2016Class IIIDrugSmart 10 Test Cup (PCP & OXY), Item No. 61020DAmeditech, Inc.JXM
Z-0492-2016Class IIIDrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5Ameditech, Inc.JXM
Z-0491-2016Class IIICLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5Ameditech, Inc.JXM
Z-0490-2016Class IIIBZO Strip Dip Card (300ng/ml)*, Item No. 100170Ameditech, Inc.JXM
Z-0489-2016Class III6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUPAmeditech, Inc.JXM
Z-0488-2016Class III12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX...Ameditech, Inc.JXM
Z-0487-2016Class III11 Panel Card (OPI 300) w/Adult, Item No. 71125AAAmeditech, Inc.JXM
Z-0486-2016Class III11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AAAmeditech, Inc.JXM
Z-0564-2016Class IIRadiographic Transparency for Certain and External Connection Tapered Implants. Images...ZimVie US Corp LLCNDP
Z-0485-2016Class III10-Panel Pipette Drug Screen, Item No. PSP-10MAmeditech, Inc.JXM
Z-0484-2016Class III1 Step 12 Panel Cup, Item No. NBCA-12M-WAmeditech, Inc.JXM
Z-0414-2016Class IIGE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are...GE HealthcareIZI
Z-0413-2016Class IIGE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated...GE HealthcareIZI
Z-0446-2016Class IIIntravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42...Edwards Lifesciences LLCDXO
Z-0404-2016Class IIZimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile...Sterilmed IncKCY
Z-0589-2016Class IIMaquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product...Maquet Cardiovascular Us Sales, LLCDWC
Z-0580-2016Class IICONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is...Thuasne, LLCITQ
Z-0579-2016Class IIADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace...Thuasne, LLCITQ
Z-0578-2016Class IIBRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee...Thuasne, LLCITQ
Z-0577-2016Class IIORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee...Thuasne, LLCITQ
Z-0576-2016Class IIHAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace...Thuasne, LLCITQ
Z-0575-2016Class IICT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace...Thuasne, LLCITQ
Z-0574-2016Class IICorflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is...Thuasne, LLCITQ
Z-0412-2016Class IIDigital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen)...180 Innovations LLCFLL
Z-0360-2016Class IPerseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults...Draeger, Inc.BSZ
Z-0455-2016Class IIAlaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal...CareFusion 303, IncCCK
Z-1044-2016Class IINebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray...ConvaTec LimitedLCQ
Z-0581-2016Class IINatus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus...Natus Medical IncorporatedGWQ
Z-0619-2016Class IISiemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in...Siemens Healthcare Diagnostics Inc.JHX
Z-0618-2016Class IISiemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnosticSiemens Healthcare Diagnostics Inc.DDR
Z-0617-2016Class IISiemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for...Siemens Healthcare Diagnostics Inc.DHA
Z-0616-2016Class IISiemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for...Siemens Healthcare Diagnostics Inc.NQD
Z-0615-2016Class IISiemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for...Siemens Healthcare Diagnostics Inc.DHA
Z-0614-2016Class IISiemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for...Siemens Healthcare Diagnostics Inc.NQD
Z-0613-2016Class IISiemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB...Siemens Healthcare Diagnostics Inc.JHX
Z-0612-2016Class IISiemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement...Siemens Healthcare Diagnostics Inc.DDR
Z-0611-2016Class IISiemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnosticSiemens Healthcare Diagnostics Inc.DAP
Z-0610-2016Class IISiemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative...Siemens Healthcare Diagnostics Inc.NBC
Z-0609-2016Class IISiemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac...Siemens Healthcare Diagnostics Inc.MMI
Z-1696-2016Class IIPhilips Healthcare DuraDiagnost stationary X-ray systemPhilips North America LLCKPR
Z-1695-2016Class IIPhilips Healthcare DigitalDiagnost stationary X-ray systemPhilips North America LLCMQB
Z-0622-2016Class IIUniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine...Orthopediatrics CorpNKB
Z-0448-2016Class IITray Set containing multiple instruments and may contain the flexible bone awl, flexible...Aesculap IncLRZ
Z-0424-2016Class IIFlexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments...Aesculap IncLRZ
Z-0423-2016Class IIFlexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These...Aesculap IncLRZ
Z-0453-2016Class IIZimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger...Zimmer GmbHHAB
Z-0760-2016Class IIArctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient...C.R. Bard IncDWJ
Z-0461-2016Class IIReagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent...Siemens Healthcare Diagnostics Inc.JJE