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-0999-03 | Portex Profile Soft-Seal Cuff Oral/Nasal Tracheal Tube, Clear Murphy Eye 8 mm x... | Abbott Medical | |||
| Z-0998-03 | Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5 mmx 25cm Reference Number... | Abbott Medical | |||
| Z-0997-03 | Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised 5 mm x 25cm Reference... | Abbott Medical | |||
| Z-0996-03 | Portex Uncuffed Oral/Nasal Tracheal Tube, Murphy Eye Clear 3.5 mm x 19cm Reference... | Abbott Medical | |||
| Z-0995-03 | Portex Uncuffed Oral Tracheal Tubes, Siliconized 6mm x 19cm Reference Number: 100/126/060 | Abbott Medical | |||
| Z-0994-03 | Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 8mm x 33cm Reference Number... | Abbott Medical | |||
| Z-0993-03 | Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3.5mm x 19cm Reference Number... | Abbott Medical | |||
| Z-0992-03 | Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3mm x 17cm Reference Number... | Abbott Medical | |||
| Z-0991-03 | Portex Uncuffed Nasal Tracheal Tubes, Ivory 5mm x 25cm Reference Number: 100/105/050 | Abbott Medical | |||
| Z-0913-03 | Custom Kit | Merit Medical Systems, Inc. | DQO | ||
| Z-0912-03 | Inject 10 Coronary Control Syringe (CCS), 10ml | Merit Medical Systems, Inc. | FMF | ||
| Z-0729-03 | HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE... | Health Care Manufacturing Inc | KPR | ||
| Z-0926-03 | Misys Laboratory System, version 5.3 | CliniSys, Inc | JQP | ||
| Z-0936-03 | Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and... | Abbott Medical | FPA | ||
| Z-0934-03 | T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible... | Abbott Medical | FPA | ||
| Z-0915-03 | LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2... | Abbott Medical | FRN | ||
| Z-0914-03 | LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection... | Abbott Medical | FPA | ||
| Z-0935-03 | Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500... | Sanarus Medical, Inc. | KNW | ||
| Z-0932-03 | Synapse Version 2.2.1 and 2.3.1 software | FUJIFILM Healthcare Americas Corporation | LLZ | ||
| Z-0947-03 | Uroview 2600 Uroview System | GE Healthcare | JAA | ||
| Z-0946-03 | Uroview 2500 X-ray System | GE Healthcare | JAA | ||
| Z-0945-03 | Uroview 2000 X-ray System | GE Healthcare | JAA | ||
| Z-0925-03 | StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL... | Venetec Intl., Inc. | FPA | ||
| Z-0924-03 | Products are surgical drills packaged separately or included in a surgical kit so two... | ZimVie US Corp LLC | DZE | ||
| Z-0923-03 | Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm... | ZimVie US Corp LLC | DZE | ||
| Z-0960-03 | Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. | LivaNova USA, Inc. | DTN | ||
| Z-0872-03 | ACCESS Estradiol Reagent Test System | Siemens Healthcare Diagnostics Inc. | CHP | ||
| Z-0012-04 | Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number... | Roche Diagnostics GmbH | |||
| Z-0954-03 | Evita 4 Continuous Ventilator | Draeger, Inc. | CBK | ||
| Z-0928-03 | iVIEW DAB Detecion Kit. Catalog Number 760-091 | Ventana Medical Systems Inc | KTO | ||
| Z-0918-03 | 2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled... | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | HNN | ||
| Z-0862-03 | MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13 | Abbott Vascular | MAF | ||
| Z-0897-03 | Contak TR Multiprogrammable Pacemaker, DDDR Model 1241 | Boston Scientific Corporation | DXY | ||
| Z-0896-03 | Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1298 | Boston Scientific Corporation | DXY | ||
| Z-0895-03 | Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1297 | Boston Scientific Corporation | DXY | ||
| Z-0894-03 | Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1296 | Boston Scientific Corporation | DXY | ||
| Z-0893-03 | Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1295 | Boston Scientific Corporation | DXY | ||
| Z-0892-03 | Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1294 | Boston Scientific Corporation | DXY | ||
| Z-0891-03 | Insignia Plus Multiprogrammable Pacemaker, DDD Model 986 | Boston Scientific Corporation | DXY | ||
| Z-0890-03 | Insignia Plus Multiprogrammable Pacemaker, DDD Model 985 | Boston Scientific Corporation | DXY | ||
| Z-0889-03 | Meridian Multiprogrammable Pacemaker, DDDR Model 1276 | Boston Scientific Corporation | DXY | ||
| Z-0888-03 | Meridian Multiprogrammable Pacemaker, DDDR Model 1275 | Boston Scientific Corporation | DXY | ||
| Z-0887-03 | Discovery II Multiprogrammable Pacemaker, DDDR Model 1283 | Boston Scientific Corporation | DXY | ||
| Z-0886-03 | Discovery II Multiprogrammable Pacemaker, DDDR Model 1280 | Boston Scientific Corporation | DXY | ||
| Z-0885-03 | Discovery II Multiprogrammable Pacemaker, DDD Model 981 | Boston Scientific Corporation | DXY | ||
| Z-0884-03 | Discovery Multiprogrammable Pacemaker, DDDR Model 1274 | Boston Scientific Corporation | DXY | ||
| Z-0883-03 | Discovery Multiprogrammable Pacemaker, DDDR Model 1273 | Boston Scientific Corporation | DXY | ||
| Z-0882-03 | Pulsar Max II Multiprogrammable Pacemaker, DDDR Model 1286 | Boston Scientific Corporation | DXY | ||
| Z-0881-03 | Pulsar Max II Multiprogrammable Pacemaker, DDDR Model 1284 | Boston Scientific Corporation | DXY | ||
| Z-0880-03 | Pulsar Max Multiprogrammable Pacemaker | Boston Scientific Corporation | DXY |