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-1007-2022 | Class II | ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery. | Carl Zeiss Meditec Inc | HNQ | |
| Z-0919-2022 | Class II | MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c)... | GE Healthcare | DQK | |
| Z-0905-2022 | Class II | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 | Stanbio Laboratory | QEI | |
| Z-0902-2022 | Class II | Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves | Medtronic, Inc. | KGO | |
| Z-0993-2022 | Class II | PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 | Baxter Healthcare Corporation | KDI | |
| Z-0992-2022 | Class II | PrisMax System, Product Code 955724 | Baxter Healthcare Corporation | KDI | |
| Z-0991-2022 | Class II | PrisMax System, Product Code 955626 | Baxter Healthcare Corporation | KDI | |
| Z-0940-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | DRX | |
| Z-0939-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | DRX | |
| Z-0938-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | DRX | |
| Z-0937-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | DRX | |
| Z-0936-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | DRX | |
| Z-0935-2022 | Class II | CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | DRX | |
| Z-0843-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller... | Augustine Temperature Management, LLC | DWJ | |
| Z-0842-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller... | Augustine Temperature Management, LLC | DWJ | |
| Z-0841-2025 | Class II | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with... | Augustine Temperature Management, LLC | DWJ | |
| Z-0840-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller... | Augustine Temperature Management, LLC | DWJ | |
| Z-0839-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller... | Augustine Temperature Management, LLC | DWJ | |
| Z-1091-2022 | Class II | ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System... | Neuralynx, Inc. | GXY | |
| Z-0918-2022 | Class I | Cub 2 Enclosed Bed Canopy System | Sensory Medical Inc | OYS | |
| Z-1029-2022 | Class II | VELYS Robotic-Assisted Solution Base Product No.: 451570100 | Depuy Orthopaedics Inc. | OLO | |
| Z-1090-2022 | Class II | Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3... | Total Resources Intl | LRR | |
| Z-1089-2022 | Class II | Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK... | Total Resources Intl | LRR | |
| Z-0946-2022 | Class II | Virus Counter Platform with Model Name VC3100 | Sartorius, Inc. | REQ | |
| Z-0925-2022 | Class II | Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority... | Abbott Vascular | MAV | |
| Z-0924-2022 | Class II | INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) | Abbott Vascular | MAV | |
| Z-0923-2022 | Class II | 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) | Abbott Vascular | MAV | |
| Z-0922-2022 | Class II | 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01... | Abbott Vascular | MAV | |
| Z-0893-2022 | Class II | Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0921-2022 | Class II | 20/30 Indeflator -Ref 1000184 Wpl2122268-01 (2019-03-01) | Abbott Vascular | MAV | |
| Z-0990-2022 | Class II | Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q | Abbott Medical | LWS | |
| Z-0989-2022 | Class II | Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q | Abbott Medical | LWS | |
| Z-0988-2022 | Class II | Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q | Abbott Medical | LWS | |
| Z-0965-2022 | Class II | Merlin 2 PCS MER3700 programmer Model MER3400 software | Abbott Medical | NIK | |
| Z-0964-2022 | Class II | Merlin PCS 3650 programmer Model 3330 software | Abbott Medical | OSR | |
| Z-0853-2022 | Class II | EasyFuse Dynamic Compression System Instrument Pack | Wright Medical Technology Inc | JDR | |
| Z-1008-2022 | Class II | RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a... | Roche Diabetes Care, Inc. | JQP | |
| Z-1018-2022 | Class II | BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version... | Becton Dickinson & Co | JQP | |
| Z-0941-2022 | Class II | Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box | MEDLINE INDUSTRIES, LP - Northfield | CAE | |
| Z-0959-2022 | Class II | 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 | Acumed LLC | HWC | |
| Z-0958-2022 | Class II | 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 | Acumed LLC | HWC | |
| Z-1057-2022 | Class II | OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 | Simplivia Healthcare Ltd. | ONB | |
| Z-1049-2022 | Class II | BF-1TQ180: EVIS EXERA II Bronchovideoscope | OLYMPUS Corporation of the Americas | EOQ | |
| Z-1048-2022 | Class II | BF-MP160F: EVIS EXERA Bronchofibervideoscope | OLYMPUS Corporation of the Americas | EOQ | |
| Z-1047-2022 | Class II | BF-3C160: EVIS EXERA Bronchovideoscope | OLYMPUS Corporation of the Americas | EOQ | |
| Z-1046-2022 | Class II | BF-MP60: OES Bronchofiberscope | OLYMPUS Corporation of the Americas | EOQ | |
| Z-0932-2022 | Class II | Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and... | MEDLINE INDUSTRIES, LP - Northfield | JIN | |
| Z-0933-2022 | Class II | Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels... | MEDLINE INDUSTRIES, LP - Northfield | DKB | |
| Z-0891-2022 | Class II | ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin... | Abbott Medical | JIS | |
| Z-0916-2022 | Class II | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support | Boston Scientific Corporation | MCX |