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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 333 of 1190
FDA device recalls, page 333 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2726-2020Class IIRusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The...Teleflex MedicalCCW
Z-2687-2020Class IISysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a...Sysmex America, Inc.PER
Z-1222-2022Class IIDYNEX Agility, Agility Analyzer, Model No. 67000Dynex Technologies, Inc.LXG
Z-2815-2020Class IIPAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1Whirlpool CorporationNZJ
Z-0511-2021Class IIREF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2...Abbott MedicalFMG
Z-0123-2021Class ISpectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare CorporationFRN
Z-0122-2021Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)Baxter Healthcare CorporationFRN
Z-0121-2021Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)Baxter Healthcare CorporationFRN
Z-0120-2021Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)Baxter Healthcare CorporationFRN
Z-2725-2020Class IIClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR...MEDLINE INDUSTRIES, LP - NorthfieldBSY
Z-2724-2020Class IIClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL...MEDLINE INDUSTRIES, LP - NorthfieldBSY
Z-2747-2020Class IIDCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW...Siemens Healthcare Diagnostics Inc.LCP
Z-2749-2020Class IIPleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST...Teleflex MedicalKDQ
Z-2736-2020Class IAlaris Pump Module Model 8100CareFusion 303, IncFRN
Z-2748-2020Class IIPleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST...Teleflex MedicalKDQ
Z-2738-2020Class IICentrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or...Hill-Rom Inc.FNL
Z-2737-2020Class IIProgressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent...Hill-Rom Inc.FNL
Z-2826-2020Class IIAlaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide...CareFusion 303, IncFRN
Z-2825-2020Class IIAlaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare...CareFusion 303, IncFRN
Z-2824-2020Class IIAlaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare...CareFusion 303, IncFRN
Z-2823-2020Class IIAlaris Syringe Module Model 8110 - Product Usage: is intended to provide trained...CareFusion 303, IncFRN
Z-2822-2020Class IIAlaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare...CareFusion 303, IncFRN
Z-2741-2020Class IAlaris System PC Unit Model 8015. modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-2740-2020Class IAlaris System PC Unit Model 8000 modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-2723-2020Class IAlaris Auto ID Module Model 8600, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-2722-2020Class IAlaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring...CareFusion 303, IncFRN
Z-2721-2020Class IAlaris EtCO2 Module Model 8300, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-2720-2020Class IAlaris PCA Module Model 8120, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-2719-2020Class IAlaris Syringe Module Model 8110, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-2697-2020Class IIIntelliVue MX700 patient monitor, model no. 865241Philips North America LLCMHX
Z-2696-2020Class IIIntelliVue MX800 patient monitor, model no. 865240Philips North America LLCMHX
Z-2718-2020Class IAlaris Pump Module Model 8100, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-2717-2020Class IAlaris System PC Unit Model 8015, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-2716-2020Class IAlaris System PC Unit Model 8000, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-2777-2020Class IIPERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for...Smith & Nephew, Inc.LXH
Z-2805-2020Class IIPVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients...Precision Valve & Automation,IncBTL
Z-2753-2020Class IIRandox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test...Randox Laboratories, LimitedCHI
Z-2752-2020Class IIRandox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system...Randox Laboratories, LimitedCHI
Z-2767-2020Class IIBOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503...Boss Instruments, Ltd.FHQ
Z-2751-2020Class IIRandox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is...Randox Laboratories, LimitedCHI
Z-2769-2020Class IIBeacon EUS Access System Preloaded Access 135degree Needle sterile, single-use...Medtronic, Inc.FCG
Z-2768-2020Class IIBeacon EUS Access System Preloaded Access 90degree Needle sterile, single-use...Medtronic, Inc.FCG
Z-2735-2020Class IMedfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.Abbott MedicalFRN
Z-2734-2020Class IMedfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1Abbott MedicalFRN
Z-2700-2020Class IIInnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity...STERIS CorporationFLG
Z-2689-2020Class IIIntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System...Philips North America LLCMHX
Z-3004-2020Class IIIPrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST...DNA Genotek Inc.PPM
Z-2733-2020Class IISterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product...Arthrex GmbHHRS
Z-2688-2020Class IIsyngo.via RT Image Suite with software versions syngo.via VB30 or VB40Siemens Medical Solutions USA, Inc.MUJ
Z-2702-2020Class IISmith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated...Smith & Nephew, Inc.HRX