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 324 of 1190
FDA device recalls, page 324 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0117-2021Class IIAltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number...Encore Medical, LPKWS
Z-3017-2020Class IIOlympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF...OLYMPUS Corporation of the AmericasEOQ
Z-0119-2021Class IIOlympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an...OLYMPUS Corporation of the AmericasFBN
Z-2970-2020Class IISiemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of...Siemens Healthcare Diagnostics Inc.CGA
Z-3027-2020Class IIVACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product...Greiner Bio-One North America, Inc.JKA
Z-2946-2020Class IIBivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide...Abbott MedicalJOH
Z-0104-2021Class IIIAlbumin Gen.2, Catalog 05166861190Roche Diagnostics GmbHCIX
Z-0103-2021Class IIITina-quant Complement C4 ver.2, Catalog 05991994190Roche Diagnostics GmbHDBI
Z-3055-2020Class IIPacific Xtreme (PTCA Balloon Dilation Catheter)Medtronic, Inc.LIT
Z-3006-2020Class IIBECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.Siemens Healthcare Diagnostics Inc.CGI
Z-2989-2020Class IIEVOLVE STEM 8.5MM Model # 496S085Wright Medical Technology IncKWI
Z-0134-2021Class IISiemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro...Siemens Healthcare Diagnostics Inc.CJO
Z-0089-2021Class IRashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single...Medtronic, Inc.DXF
Z-0088-2021Class IRashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single...Medtronic, Inc.DXF
Z-0115-2021Class IIAtellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI...Siemens Healthcare Diagnostics Inc.NCW
Z-0072-2021Class IIChange Healthcare Radiology Solutions 14.0Change Healthcare Canada CompanyLLZ
Z-0087-2021Class IRashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric...Medtronic, Inc.DXF
Z-2961-2020Class IITerumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791...Terumo Cardiovascular Systems CorporationDTQ
Z-2960-2020Class IITerumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number...Terumo Cardiovascular Systems CorporationDTQ
Z-2959-2020Class IITerumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773...Terumo Cardiovascular Systems CorporationDTQ
Z-0094-2021Class IIAquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids...Genicon, Inc.N/A
Z-0181-2021Class IIOpticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date...Boston Scientific CorporationOBJ
Z-3020-2020Class IIEquinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.Exactech, Inc.PHX
Z-3019-2020Class IIEquinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.Exactech, Inc.PHX
Z-2945-2020Class IIEVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for...Smith & Nephew, Inc.HRS
Z-3012-2020Class IIInquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR...Irvine Biomedical. Inc.DRF
Z-3011-2020Class IIInquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR...Irvine Biomedical. Inc.DRF
Z-0095-2021Class IIAlcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex...Alcon LaboratoriesLRO
Z-2972-2020Class IIImactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in...Imactis, SASJAK
Z-3018-2020Class II4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits...North American Rescue LLC.FQM
Z-0096-2021Class IISwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE...Direct Healthcare Group Sverige ABFSA
Z-2981-2020Class IIElecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190Roche Diagnostics GmbHJZO
Z-2925-2020Class IICirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of...Brainlab, Inc.OLO
Z-0052-2021Class IIDimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro...Siemens Healthcare Diagnostics Inc.MMI
Z-0051-2021Class IIMICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination...Ansell Healthcare Products LLCLYY
Z-3005-2020Class IISoftware: Syngo.via RT Image Suite software version VA30_SP02 with license...Siemens Medical Solutions USA, Inc.MUJ
Z-3051-2020Class IIDrug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI...Ameditech, Inc.DIO
Z-3050-2020Class IIFirst Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100BAmeditech, Inc.DKZ
Z-3049-2020Class IIFirst Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100BAmeditech, Inc.DKZ
Z-3048-2020Class IIFirst Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600BAmeditech, Inc.DKZ
Z-3047-2020Class IIFirst Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700BAmeditech, Inc.LDJ
Z-3046-2020Class IIFirst Check 1 Panel Drug Cup: (THC); AMT Item Number 990400BAmeditech, Inc.DKC
Z-3045-2020Class IIToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup Drug Screen...Ameditech, Inc.DIO
Z-3044-2020Class IITDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse...Ameditech, Inc.DIO
Z-3043-2020Class IIQuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox Drug Screen...Ameditech, Inc.DIO
Z-3042-2020Class IIProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs...Ameditech, Inc.DKC
Z-3041-2020Class IIOratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT...Ameditech, Inc.LDJ
Z-3040-2020Class IIiCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup"...Ameditech, Inc.LDJ
Z-3039-2020Class IINoble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step +...Ameditech, Inc.LDJ
Z-3038-2020Class IIMicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU /...Ameditech, Inc.DKC