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-1356-2022 | Class II | MiniMed 720G Insulin Pump (O.U.S. Version) | Medtronic, Inc. | OYC | |
| Z-1355-2022 | Class II | MiniMed 670G Insulin Pump (U.S. and O.U.S. Version) | Medtronic, Inc. | OZP | |
| Z-1354-2022 | Class II | MiniMed 640G Insulin Pump (O.U.S. Version) | Medtronic, Inc. | OYC | |
| Z-1353-2022 | Class II | MiniMed 630G Insulin Pump (U.S. and Canada Version) | Medtronic, Inc. | OZO | |
| Z-1352-2022 | Class II | MiniMed 620G Insulin Pump (O.U.S. version) | Medtronic, Inc. | OYC | |
| Z-1384-2022 | Class III | Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP... | Agilent Technologies, Inc. | PPM | |
| Z-1365-2022 | Class II | Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal... | Draeger Medical Systems, Inc. | FPL | |
| Z-1345-2022 | Class II | CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of... | Menarini Silicon Biosystems Inc. | NQI | |
| Z-1342-2022 | Class II | Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1324-2022 | Class II | EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use... | DePuy Spine, Inc. | MAX | |
| Z-1323-2022 | Class II | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use... | DePuy Spine, Inc. | MAX | |
| Z-1295-2022 | Class II | regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. | ROi CPS LLC | OEZ | |
| Z-1363-2022 | Class II | PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog... | Cordis US Corp. | FGE | |
| Z-1337-2022 | Class II | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II | Chromsystems Instruments & Chemicals GmbH | JJY | |
| Z-1336-2022 | Class II | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I | Chromsystems Instruments & Chemicals GmbH | JJY | |
| Z-1293-2022 | Class II | Sensica Urine Output System | C.R. Bard Inc | EXS | |
| Z-1375-2022 | Class II | MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral... | Depuy Orthopaedics Inc. | LZY | |
| Z-1458-2022 | Class II | Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816... | Paragon 28 | HRS | |
| Z-1341-2022 | Class II | Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac... | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-1340-2022 | Class II | Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac... | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-1321-2022 | Class II | ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 | Radiometer Medical ApS | CHL | |
| Z-1510-2022 | Class II | 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide... | Medical Modeling - a 3D Systems Company | DZJ | |
| Z-1288-2022 | Class II | #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED | Baxter Healthcare Corporation | CCW | |
| Z-1270-2022 | Class II | Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 | Volcano Corporation | DXQ | |
| Z-1211-2022 | Class I | Drager SafeStar 55, Catalog No. MP01790 | Draeger, Inc. | CAH | |
| Z-1322-2022 | Class II | EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25... | Medtronic, Inc. | GAG | |
| Z-1338-2022 | Class II | RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection... | Rayner Intraocular Lenses Limited | HQL | |
| Z-1251-2022 | Class II | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 | Neumodx Molecular, Inc. | QLT | |
| Z-1302-2022 | Class III | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only... | Volcano Corporation | OBJ | |
| Z-1301-2022 | Class III | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only... | Volcano Corporation | OBJ | |
| Z-1287-2022 | Class II | Medline Pill Splitters; 1 each/box; 144 boxes/carton | MEDLINE INDUSTRIES, LP - Northfield | OHY | |
| Z-1269-2022 | Class II | Alcon Clareon IOL with AutonoMe Delivery System | Alcon Laboratories Ireland, Ltd | HQL | |
| Z-1688-2022 | Class II | VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS | Gyn-Disposables, Inc. | OXQ | |
| Z-1265-2022 | Class II | CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update... | GE Healthcare | DXJ | |
| Z-1591-2023 | Class II | Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove... | Dynasthetics | CBN | |
| Z-1441-2022 | Class II | Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1440-2022 | Class II | Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1439-2022 | Class II | BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1438-2022 | Class II | BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1437-2022 | Class II | BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1436-2022 | Class II | BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1435-2022 | Class II | BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1434-2022 | Class II | BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1433-2022 | Class II | BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1432-2022 | Class II | BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS) | Becton Dickinson & Co | FMG | |
| Z-1431-2022 | Class II | BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500... | Becton Dickinson & Co | FMG | |
| Z-1308-2022 | Class II | VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM... | Maquet Cardiovascular Us Sales, LLC | FSY | |
| Z-1125-2022 | Class III | KWIK-STIK" plus: Clostridium perfringens | Microbiologics, Inc. | JTR | |
| Z-1257-2022 | Class II | DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 | Encore Medical, LP | JWH | |
| Z-1266-2022 | Class I | HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device... | Medtronic, Inc. | DSQ |