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-1884-2010 | Navilyst Medical, Inc. Vaxcel(TM) Port titanium Standard Port with 9F Polyurethane... | Boston Scientific Corporation | LJT | ||
| Z-1883-2010 | Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F Silicone Catheter (1.5... | Boston Scientific Corporation | LJT | ||
| Z-1882-2010 | Navilyst Medical, Inc. Vaxcel(TM) Port titanium Mini-Port with 7F Polyurethane Catheter... | Boston Scientific Corporation | LJT | ||
| Z-1881-2010 | Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane Catheter... | Boston Scientific Corporation | LJT | ||
| Z-1880-2010 | Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic Standard Port with PASV... | Boston Scientific Corporation | LJT | ||
| Z-1879-2010 | Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Plastic Standard Port with PASV... | Boston Scientific Corporation | LJT | ||
| Z-1878-2010 | Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV... | Boston Scientific Corporation | LJT | ||
| Z-1877-2010 | Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV... | Boston Scientific Corporation | LJT | ||
| Z-1876-2010 | Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve... | Boston Scientific Corporation | LJT | ||
| Z-1875-2010 | Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve... | Boston Scientific Corporation | LJT | ||
| Z-1874-2010 | Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve... | Boston Scientific Corporation | LJT | ||
| Z-1808-2010 | Harris Medical UV Lamp; the device does not have a label identifying the name and place... | Harris Medical Resources | MXG | ||
| Z-1968-2010 | Stryker 18 MM AVS TL Trial Spacer; Catalog number: 48389418. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1967-2010 | Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417 Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1966-2010 | Stryker 16 MM AVS TL Trial Spacer; Catalog number: 48389416. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1965-2010 | Stryker 15 MM AVS TL Trial Spacer; Catalog number: 48389415. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1964-2010 | Stryker 14 MM AVS TL Trial Spacer; Catalog number: 48389414. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1963-2010 | Stryker 13 MM AVS TL Trial Spacer; Catalog number: 48389413. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1962-2010 | Stryker 12 MM AVS TL Trial Spacer; Catalog number: 48389412. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1961-2010 | Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1960-2010 | Stryker 10 MM AVS TL Trial Spacer; Catalog number: 48389410. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1959-2010 | Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1958-2010 | Stryker 8 MM AVS TL Trial Spacer; Catalog number: 48389408. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-1957-2010 | Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407. Manufactured by: Stryker... | Howmedica Osteonics Corp | MDM | ||
| Z-2114-2010 | Microwave Ovens, Model Number DG-2 | Duke Manufacturing Co. | RCS | ||
| Z-2221-2010 | BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA... | Insight Instruments, Inc. | KYG | ||
| Z-2220-2010 | CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured... | Insight Instruments, Inc. | KYG | ||
| Z-1755-2010 | The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management... | Baylis Medical Co., Inc. | GXI | ||
| Z-1890-2010 | TAUT ADAPt Balloon Open Access Port And Syringe 10/12mm x 100mm, REF 41244, Rx Only... | Teleflex Medical | GCJ | ||
| Z-1002-2011 | Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540... | Stryker Corp. | FAT | ||
| Z-2592-2011 | Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in... | Elekta Limited | MUJ | ||
| Z-1998-2010 | O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for... | Medtronic Navigation, Inc | LLZ | ||
| Z-1800-2010 | InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical... | Inviro Medical Devices, Inc. | MEG | ||
| Z-1778-2010 | NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio... | Ohio Medical LLC | BTA | ||
| Z-1813-2010 | System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and... | Datascope Corp. | DSP | ||
| Z-1812-2010 | CS300 Intra-Aortic Balloon Pump | Datascope Corp. | DSP | ||
| Z-1811-2010 | CS100 Intra-Aortic Balloon Pump. | Datascope Corp. | DSP | ||
| Z-1777-2010 | MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides... | Ohio Medical LLC | BTA | ||
| Z-0329-2011 | Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc... | Cutera Inc | ILY | ||
| Z-1735-2010 | Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson... | Change Healthcare Canada Company | LLZ | ||
| Z-2588-2010 | Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage... | Integra LifeSciences Corporation | GCY | ||
| Z-1774-2010 | Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps UPN/Catalog... | Boston Scientific Corporation | FCL | ||
| Z-1773-2010 | Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80... | Boston Scientific Corporation | FCL | ||
| Z-1772-2010 | Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm... | Boston Scientific Corporation | FCL | ||
| Z-2293-2010 | HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx... | Philips North America LLC | MKJ | ||
| Z-1801-2010 | GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The... | GE Healthcare | MHX | ||
| Z-0940-2011 | Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet... | Maquet Cardiovascular LLC | DXC | ||
| Z-0132-2011 | PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street... | Escalon Medical Corp | DPW | ||
| Z-0118-2011 | Medtronic Virtuoso II VR, model D274VRC, and model D294VRC not available in the U.S... | Medtronic, Inc. | NIK | ||
| Z-0117-2011 | Medtronic Virtuoso II DR, model D274DRG, and model D294DRG not available in the U.S... | Medtronic, Inc. | NIK |
