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 349 of 1190
FDA device recalls, page 349 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0102-2022Class IIsmiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093Abbott MedicalDRO
Z-0101-2022Class IIsmiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092Abbott MedicalDRO
Z-0100-2022Class IIsmiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091Abbott MedicalDRO
Z-0099-2022Class IIsmiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090Abbott MedicalDRO
Z-0098-2022Class IIsmiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number...Abbott MedicalDRO
Z-0097-2022Class IIsmiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number...Abbott MedicalDRO
Z-0096-2022Class IIsmiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number...Abbott MedicalDRO
Z-0095-2022Class IIsmiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number...Abbott MedicalDRO
Z-0094-2022Class IIsmiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076Abbott MedicalDRO
Z-0093-2022Class IIsmiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure...Abbott MedicalDRO
Z-0092-2022Class IImedex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b)...Abbott MedicalDRO
Z-0109-2021Class IISkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a...Skytron, LLCLMD
Z-1834-2020Class IIIVITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468Ortho-Clinical Diagnostics, Inc.KLI
Z-1885-2020Class IIACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA)...Northgate Technologies Inc.FFK
Z-1884-2020Class IIAUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes...Northgate Technologies Inc.FFK
Z-1883-2020Class IIProbe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for...Northgate Technologies Inc.FFK
Z-1684-2020Class IIABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood...Radiometer Medical ApSCHL
Z-2040-2020Class IICustom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1703-2020Class IIThe CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines...Sysmex America, Inc.LXG
Z-1728-2020Class IIARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.Abbott MedicalLOL
Z-1740-2020Class IIPolaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080Boston Scientific CorporationEZB
Z-1739-2020Class IIStretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080Boston Scientific CorporationEZB
Z-1738-2020Class IIStretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080Boston Scientific CorporationEZB
Z-1737-2020Class IIStretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080Boston Scientific CorporationEZB
Z-1736-2020Class IIContour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080Boston Scientific CorporationEZB
Z-1735-2020Class IIPercuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited...Boston Scientific CorporationEZB
Z-1734-2020Class IIPercuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110Boston Scientific CorporationEZB
Z-1733-2020Class IIPercuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110Boston Scientific CorporationEZB
Z-1732-2020Class IISensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5...Boston Scientific CorporationEZB
Z-1731-2020Class IISensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5...Boston Scientific CorporationEZB
Z-1730-2020Class IISensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5...Boston Scientific CorporationEZB
Z-1729-2020Class IISensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5...Boston Scientific CorporationEZB
Z-1955-2020Class IITandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product...Cardiac Assist, IncKFM
Z-1954-2020Class IITandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118...Cardiac Assist, IncKFM
Z-1953-2020Class IITandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631...Cardiac Assist, IncKFM
Z-1952-2020Class IITandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118...Cardiac Assist, IncKFM
Z-1951-2020Class IITandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916...Cardiac Assist, IncKFM
Z-1950-2020Class IITandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217...Cardiac Assist, IncKFM
Z-1949-2020Class IITandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215...Cardiac Assist, IncKFM
Z-1948-2020Class IITandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary...Cardiac Assist, IncKFM
Z-1858-2020Class IIChest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up...R82 a/SITJ
Z-1566-2020Class IISpectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number...Cook IncorporatedFOZ
Z-1565-2020Class IIPericardiocentesis Set, Irrigation Catheter, Reference Part Number...Cook IncorporatedGBX
Z-1836-2020Class IIABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004Radiometer Medical ApSCHL
Z-2781-2020Class IIIAVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for...Linet AmericasHDD
Z-1569-2020Class IISkytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount...Skytron, LLCFQO
Z-1767-2020Class IITRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes...Philips North America LLCMHX
Z-1766-2020Class IITRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers...Philips North America LLCMHX
Z-1801-2020Class IIPhillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in...Philips North America LLCJAA
Z-1630-2020Class IInatus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalographNatus Medical IncorporatedOMA