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-0647-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 2.0 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0646-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.7 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0645-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.5 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0644-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.2 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0643-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.0 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0757-04 | NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for... | Welch Allyn Inc | DXQ | ||
| Z-0756-04 | NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for... | Welch Allyn Inc | DXQ | ||
| Z-0755-04 | NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for... | Welch Allyn Inc | DXQ | ||
| Z-0754-04 | NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for... | Welch Allyn Inc | DXQ | ||
| Z-753-04 | NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for... | Welch Allyn Inc | DXQ | ||
| Z-0752-04 | NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for... | Welch Allyn Inc | DXQ | ||
| Z-0751-04 | NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for... | Welch Allyn Inc | DXQ | ||
| Z-0750-04 | NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for... | Welch Allyn Inc | DXQ | ||
| Z-0749-04 | NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff, for... | Welch Allyn Inc | DXQ | ||
| Z-0748-04 | NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for... | Welch Allyn Inc | DXQ | ||
| Z-0642-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 0.8 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-1093-04 | SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. | Bausch & Lomb Incorporated | HQL | ||
| Z-0720-04 | 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot... | 3M Company | FRC | ||
| Z-0727-04 | PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions... | GE Medical Systems Information Technologies, Inc. | MSX | ||
| Z-0735-04 | NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of... | bioMerieux, Inc. | JJQ | ||
| Z-0711-04 | AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog... | Greatbatch Medical | GAA | ||
| Z-0789-04 | Bemis Two-Gallon Sharps Container, Models #102 020, #102 030, and #102 040. (The only... | Bemis Manufacturing Co. | MMK | ||
| Z-0855-04 | CryoValve Conduit and Pulmonary Valve and Conduit | Artivion, Inc. | MIE | ||
| Z-0854-04 | CryoValve Aortic Valve | Artivion, Inc. | MIE | ||
| Z-0640-2007 | CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured... | Abbott Medical | GIF | ||
| Z-0766-04 | MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF | Staar Surgical AG | KYB | ||
| Z-0724-04 | IMMULITE 2000 Intact PTH kit | Siemens Healthcare Diagnostics Inc. | CEW | ||
| Z-0770-04 | Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two... | Sekisui Diagnostics, LLC | MHI | ||
| Z-0777-04 | Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156. | Zimmer GmbH | KWT | ||
| Z-0641-04 | Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75... | Gebauer Co | LFD | ||
| Z-0776-04 | CryoValve, Aortic Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0728-04 | Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The... | Eastman Kodak Company | KPR | ||
| Z-0584-04 | Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division... | Baxter Healthcare Renal Div | KDI | ||
| Z-0583-04 | Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series... | Baxter Healthcare Renal Div | FII | ||
| Z-0788-04 | Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital... | Spencer Technologies | IYN | ||
| Z-0708-04 | Endocpir, Zoom for Dyonics 3-Chip Camera Catalog Number: 7205461 | Smith & Nephew, Inc. | FXM | ||
| Z-0707-04 | Endocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M, 7204614S | Smith & Nephew, Inc. | FXM | ||
| Z-0706-04 | Endocoupler 18 MM F.L, Autoclavable Catalog Number: 7207905, 7207905S | Smith & Nephew, Inc. | FXM | ||
| Z-0705-04 | Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398 | Smith & Nephew, Inc. | FXM | ||
| Z-0704-04 | Endocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S | Smith & Nephew, Inc. | FXM | ||
| Z-0640-04 | ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH)... | Vysis | MMW | ||
| Z-0589-04 | All Outpatient and Coolspot single ceiling or single track Medical Examination Lights... | Burton Medical Products Corp. | KZF | ||
| Z-0747-04 | CryoValve, Pulmonary Valve and Conduit | Artivion, Inc. | MIE | ||
| Z-0746-04 | CryoValve, Aortic Valve and Conduit | Artivion, Inc. | MIE | ||
| Z-0780-04 | NOW Malaria (Export use only) Item Number 660-430, Kit Number 66005, Kit Number 660-000 | Abbott Diagnostics Scarborough, Inc. | NED | ||
| Z-0779-04 | NOW Filariasis Rapid test for W. bancrofti antigen. (Export use only) Item Number... | Abbott Diagnostics Scarborough, Inc. | NES | ||
| Z-0778-04 | NOW RSV Test Item Number 430-430, Kit Number 430-00R | Abbott Diagnostics Scarborough, Inc. | GQG | ||
| Z-0639-04 | Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MPB | ||
| Z-0634-04 | ATS Open Pivot Mechanical Heart Valve | Medtronic, Inc. (Minneapolis, MN 55447) | LWQ | ||
| Z-0813-04 | Medex 3000 Series Syringe Infusion Pumps | Medex Inc | CAJ |