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-1290-2022 | Class II | Arrow Three-Lumen CVC | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1242-2022 | Class II | Tornado Embolization Microcoil, RPN... | Cook Incorporated | KRD | |
| Z-1241-2022 | Class II | Nester Embolization Microcoil RPN... | Cook Incorporated | KRD | |
| Z-1240-2022 | Class II | Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN... | Cook Incorporated | KRD | |
| Z-1303-2022 | Class II | Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1225-2022 | Class II | Profemur Plasma Z Classic Stem Size 7 Standard Short Neck | Microport Orthopedics Inc. | JDI | |
| Z-1289-2022 | Class II | System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model... | Canon Medical Systems USA, Inc. | OWB | |
| Z-1255-2022 | Class II | regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003 | ROi CPS LLC | LRO | |
| Z-1260-2022 | Class II | illumina Model NextSeq 550 Dx REF 20005715 | Illumina, Inc. | PFF | |
| Z-1224-2022 | Class II | NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 | Medtronic Xomed, Inc. | GWF | |
| Z-1223-2022 | Class II | NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 | Medtronic Xomed, Inc. | GWF | |
| Z-1259-2022 | Class II | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina... | Illumina, Inc. | PFF | |
| Z-1250-2022 | Class II | Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED... | ROi CPS LLC | FDE | |
| Z-1216-2022 | Class II | Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit | TORNIER Inc. | LXH | |
| Z-1234-2022 | Class II | STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS... | Karl Storz Endoscopy-America, Inc. | FAJ | |
| Z-1277-2022 | Class I | Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT... | American Contract Systems, Inc. | JSM | |
| Z-1276-2022 | Class I | Clean Catch Urine Kit NS 178489, AHMU58A | American Contract Systems, Inc. | JSM | |
| Z-1279-2022 | Class I | Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling... | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-1278-2022 | Class I | Flow-c Anesthesia System : intended for use in administering anesthesia while... | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-0314-2025 | Class II | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and... | Nihon Kohden America Inc | CCK | |
| Z-1521-2022 | Class I | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J | Medtronic Xomed, Inc. | ETN | |
| Z-1520-2022 | Class I | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306 | Medtronic Xomed, Inc. | ETN | |
| Z-1519-2022 | Class I | NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF... | Medtronic Xomed, Inc. | ETN | |
| Z-1282-2022 | Class II | INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen... | Maquet Cardiovascular LLC | DSY | |
| Z-1360-2022 | Class II | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) | Isopure Corp | FIN | |
| Z-1233-2022 | Class II | Centricity PACS RA1000 | GE Healthcare | LLZ | |
| Z-1232-2022 | Class II | Centricity Cardiology CA1000 | GE Healthcare | LLZ | |
| Z-1231-2022 | Class II | Centricity Radiology RA600 | GE Healthcare | LLZ | |
| Z-1230-2022 | Class II | Centricity Enterprise Web | GE Healthcare | LLZ | |
| Z-1229-2022 | Class II | Centricity Universal Viewer Zero Footprint Client | GE Healthcare | LLZ | |
| Z-1213-2022 | Class II | FIRMap" Catheter, 60mm Basket | Abbott Medical | MTD | |
| Z-1404-2022 | Class II | X80 RADiant Photoelectric Therapy System | Xstrahl Limited | JAD | |
| Z-1261-2022 | Class II | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF... | Medtronic, Inc. | HCG | |
| Z-1310-2022 | Class II | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 | Haemonetics Corporation | JPA | |
| Z-1281-2022 | Class II | BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control... | Becton Dickinson & Co | GEI | |
| Z-1139-2022 | Class I | In-Line ventilator adaptor | Baxter Healthcare Corporation | NHJ | |
| Z-1138-2022 | Class I | In-Line ventilator adaptor | Baxter Healthcare Corporation | NHJ | |
| Z-1074-2022 | Class II | 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software... | The Daavlin Distributing Co. | FTC | |
| Z-1073-2022 | Class II | 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software... | The Daavlin Distributing Co. | FTC | |
| Z-1286-2022 | Class II | Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2... | GE Healthcare | BSZ | |
| Z-1283-2022 | Class II | CardioTek EP-TRACER Software V2.x. | CardioTek BV | DQK | |
| Z-1285-2022 | Class II | Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or... | GE Healthcare | BSZ | |
| Z-2635-2023 | Class II | Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part... | Fresenius Kabi USA, LLC | FRN | |
| Z-1381-2022 | Class II | Ivenix Infusion System (IIS) | Fresenius Kabi USA, LLC | PHC | |
| Z-1275-2022 | Class II | EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive... | OLYMPUS Corporation of the Americas | FDS | |
| Z-1256-2022 | Class II | Reliance Synergy Washer/Disinfector | STERIS Corporation | MEC | |
| Z-1274-2022 | Class II | Colonovideoscope Model CF-H180AL | OLYMPUS Corporation of the Americas | FDF | |
| Z-1273-2022 | Class II | REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO, | Bard Peripheral Vascular Inc | PXI | |
| Z-1133-2022 | Class II | INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right | Smith & Nephew Orthopaedics AG | JDS | |
| Z-1132-2022 | Class II | Surgical Suture Kit | Gyn-Disposables, Inc. | MCZ |