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-0393-06 | Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and... | Varian Medical Systems, Inc. | IWB | ||
| Z-0406-06 | BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and... | Becton Dickinson & Co | KZJ | ||
| Z-0905-06 | Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an... | Medtronic Neuromodulation | GZB | ||
| Z-0812-06 | MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed... | Abbott Medical | KRK | ||
| Z-0811-06 | MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief)... | Abbott Medical | GWM | ||
| Z-0354-06 | The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical... | Respironics, Inc. | CBK | ||
| Z-0279-06 | StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers... | Stryker Corp. | GCX | ||
| Z-0353-06 | CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing... | AGFA Healthcare Corp. | LLZ | ||
| Z-0352-06 | ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR... | AGFA Healthcare Corp. | KPR | ||
| Z-0322-06 | OLA 2500 Olympus Lab Automation Systems to include the following models (all serial... | OLYMPUS Corporation of the Americas | JQP | ||
| Z-0321-06 | HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode... | Philips North America LLC | MLN | ||
| Z-0347-06 | System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA... | Baxter Healthcare Renal Div | KDI | ||
| Z-0468-06 | BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has... | Becton Dickinson & Co | GCD | ||
| Z-0467-06 | BD Perisafe catheter with catheter connector. The catheter connector has four... | Becton Dickinson & Co | GCD | ||
| Z-0255-06 | A3176-18 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0254-06 | A2549-22 Spinal Needle | Abbott Medical | CAZ | ||
| Z-0253-06 | A1991-18 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0252-06 | A1967-18 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0251-06 | A1378-18 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0250-06 | A1272-17 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0249-06 | 4954-17 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0248-06 | 4954-16 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0247-06 | 4950-18 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0246-06 | 4950-17 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0245-06 | 4950-16 Portex Epidural Mini-pack | Abbott Medical | CAZ | ||
| Z-0244-06 | 4904 Glass L.O.R. Syringe | Abbott Medical | CAZ | ||
| Z-0243-06 | 4903 Glass L.O.R. Syringe | Abbott Medical | CAZ | ||
| Z-0242-06 | 4902 Glass L.O.R. Syringe | Abbott Medical | CAZ | ||
| Z-0976-2007 | Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box... | GE Healthcare | IZH | ||
| Z-1412-06 | Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns... | Joerns Healthcare | FNL | ||
| Z-1411-06 | Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed | Joerns Healthcare | FNJ | ||
| Z-0857-06 | Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) | GE Healthcare | BSZ | ||
| Z-0518-06 | Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is... | Sunrise Medical, Inc. | ITI | ||
| Z-0532-06 | Toshiba Digital Radiography System Model DFP8000D | Canon Medical Systems USA, Inc. | JAA | ||
| Z-0908-06 | Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high... | Agiliti Health - Hays | FNL | ||
| Z-0278-06 | SABINA I and SABINA II Patient Lift | Liko, Inc. | FSA | ||
| Z-0277-06 | UNO 102 Patient Lift | Liko, Inc. | FSA | ||
| Z-0276-06 | UNO 100 Patient Lift | Liko, Inc. | FSA | ||
| Z-0296-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Ant-Cer Anterior... | Spinal Concepts, Inc. | KWQ | ||
| Z-0295-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix ThinLine Anterior... | Spinal Concepts, Inc. | KWQ | ||
| Z-0294-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior... | Spinal Concepts, Inc. | KWQ | ||
| Z-0293-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine... | Spinal Concepts, Inc. | KWQ | ||
| Z-0412-06 | Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and... | Baxter Healthcare Corporation | FRN | ||
| Z-0292-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine... | Spinal Concepts, Inc. | KWQ | ||
| Z-0003-2007 | Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200) | Axis-Shield Diagnostics, Ltd. | NHX | ||
| Z-0385-06 | Clinical Chemistry Prealbumin, List Number 1E02-20 | Abbott Medical | JZJ | ||
| Z-0384-06 | Clinical Chemistry Immunoglobulin M, List Number 1E01-20 | Abbott Medical | DFT | ||
| Z-0383-06 | Clinical Chemistry Apolipoprotein A1, List Number 9D92-20 | Abbott Medical | DER | ||
| Z-0325-06 | Digital Radiography System Model DFP-8000D/FPD, | Canon Medical Systems USA, Inc. | JAA | ||
| Z-0324-06 | Digital Radiography System Model DFP8000D | Canon Medical Systems USA, Inc. | JAA |