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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2296-2021 | Class II | DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF... | Delta Med SpA | FOZ | |
| Z-2295-2021 | Class II | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c)... | Delta Med SpA | FOZ | |
| Z-2561-2021 | Class II | Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 | Novanta Medical GmbH | HIG | |
| Z-2142-2021 | Class II | ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United... | Remel Inc | JTN | |
| Z-2074-2021 | Class I | Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The... | Respironics, Inc. | MNT | |
| Z-2073-2021 | Class I | Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics... | Respironics, Inc. | MNT | |
| Z-0245-2022 | Class II | Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E... | Medicalplastic | KTT | |
| Z-2092-2021 | Class II | Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used... | Gentherm Medical, LLC | DWC | |
| Z-2244-2021 | Class I | Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number... | Medtronic, Inc. | FOS | |
| Z-2051-2021 | Class II | EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar. | Baxter Healthcare Corporation | GCJ | |
| Z-2434-2021 | Class II | Proteus 235- designed to produce and deliver a proton beam for the treatment of patients... | Ion Beam Applications S.A. | LHN | |
| Z-2169-2021 | Class II | Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which... | ROi CPS LLC | MLS | |
| Z-2168-2021 | Class II | Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which... | ROi CPS LLC | MLS | |
| Z-2167-2021 | Class II | Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which... | ROi CPS LLC | MLS | |
| Z-2107-2021 | Class II | Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC | Arthrex GmbH | MAI | |
| Z-1900-2021 | Class II | Revolution EVO, Optima CT660, Optima CT680 CT Systems. | GE Healthcare | JAK | |
| Z-1958-2021 | Class I | A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting | Respironics, Inc. | MNS | |
| Z-1957-2021 | Class I | A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous... | Respironics, Inc. | MNS | |
| Z-1956-2021 | Class I | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. | Respironics, Inc. | CBK | |
| Z-1974-2021 | Class I | SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE... | Respironics, Inc. | BZD | |
| Z-1973-2021 | Class I | DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and... | Respironics, Inc. | MNS | |
| Z-1972-2021 | Class I | Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory... | Respironics, Inc. | MNS | |
| Z-2043-2021 | Class II | CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US; | Medtronic Heart Valves Division | NPT | |
| Z-2042-2021 | Class II | CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; | Medtronic Heart Valves Division | NPT | |
| Z-2041-2021 | Class II | CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N; | Medtronic Heart Valves Division | NPT | |
| Z-2588-2021 | Class II | Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model... | ArjoHuntleigh Polska Sp. zo.o. | FNL | |
| Z-2161-2021 | Class II | OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot... | GE Healthcare | OWB | |
| Z-2160-2021 | Class II | OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage... | GE Healthcare | OXO | |
| Z-2067-2021 | Class II | Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes... | Mercedes Medical LLC | QBD | |
| Z-2166-2021 | Class II | basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate... | Merit Medical Systems, Inc. | PTM | |
| Z-2187-2021 | Class II | REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE... | Abbott Medical | CKA | |
| Z-2186-2021 | Class II | REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE... | Abbott Medical | CKA | |
| Z-2185-2021 | Class II | REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE... | Abbott Medical | CKA | |
| Z-2184-2021 | Class II | REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c... | Abbott Medical | CKA | |
| Z-2066-2021 | Class II | Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box. | Mercedes Medical LLC | QBD | |
| Z-2380-2021 | Class II | Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical... | OLYMPUS Corporation of the Americas | GEI | |
| Z-2095-2021 | Class II | Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The... | Medtronic, Inc. | MPO | |
| Z-2094-2021 | Class II | Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The... | Medtronic, Inc. | MPO | |
| Z-2079-2021 | Class II | Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and... | Cordis US Corp. | DRE | |
| Z-1995-2021 | Class II | MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The... | CareFusion 303, Inc | FPA | |
| Z-2350-2021 | Class II | Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-2318-2021 | Class II | 728333 Spectral CT 7500 -Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-2317-2021 | Class II | 728332 IQon Spectral CT-Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-2316-2021 | Class II | 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-2315-2021 | Class II | Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-2314-2021 | Class II | 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades | Philips North America LLC | JAK | |
| Z-2138-2021 | Class II | RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2136-2021 | Class II | Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF... | Medtronic, Inc. | MIH | |
| Z-2135-2021 | Class II | Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System... | Medtronic, Inc. | MIH | |
| Z-2040-2021 | Class II | FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI... | BioFire Diagnostics, LLC | QDS |