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-0780-2010 | MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system... | Philips North America LLC | LNH | ||
| Z-2218-2010 | AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter... | Spectranetics Corp. | NWX | ||
| Z-1234-2010 | ATAC Serum Control Kit. The device is used for monitoring the performance of clinical... | ELITechGroup Inc | JJY | ||
| Z-1233-2010 | Envoy 500 Serum Control Kit. The device is used for monitoring the performance of... | ELITechGroup Inc | JJY | ||
| Z-0656-2010 | Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff... | T.A.G. Medical Products Corporation Ltd | NBH | ||
| Z-2435-2010 | The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to... | Ventus Medical, Inc. | MNR | ||
| Z-1589-2010 | Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XXL; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1588-2010 | Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1587-2010 | Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block LG; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1586-2010 | Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block ML; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1585-2010 | Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block MED; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1584-2010 | Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block SM; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1583-2010 | Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XS; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1582-2010 | Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 13; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1581-2010 | Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 11; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1580-2010 | Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 9; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1579-2010 | Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 8; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1578-2010 | Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 7; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1577-2010 | Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 6; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1576-2010 | Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 5; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1575-2010 | Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 4; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-1574-2010 | Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 3; XCelerate cutting block for... | Howmedica Osteonics Corp | LXH | ||
| Z-0622-2010 | Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design... | Encore Medical, LP | JWH | ||
| Z-1815-2010 | CaviBleach Wipes; a disinfectant medical device, active ingredient Sodium hypochlorite... | Medtrol, Inc. | LRJ | ||
| Z-0652-2010 | Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical... | Teleflex Medical | BZA | ||
| Z-2690-2011 | LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy)... | LiNA Medical Inc | KNF | ||
| Z-2689-2011 | LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy)... | LiNA Medical Inc | KNF | ||
| Z-2688-2011 | LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy)... | LiNA Medical Inc | KNF | ||
| Z-1001-2011 | Varian brand C Series Clinics (Includes Trilogy, and Novalis Tx), Model Numbers: H14... | Varian Medical Systems, Inc. | IYE | ||
| Z-2219-2010 | Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used... | Accuray Incorporated | MUJ | ||
| Z-1932-2011 | Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-0913-2010 | Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI... | Horiba Instruments Incorporated | KNK | ||
| Z-0912-2010 | Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI... | Horiba Instruments Incorporated | KNK | ||
| Z-1036-2010 | Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog... | Horiba Instruments Incorporated | CGX | ||
| Z-1035-2010 | Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog #... | Horiba Instruments Incorporated | CGX | ||
| Z-0610-2010 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the... | Boston Scientific Corporation | LWP | ||
| Z-0609-2010 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models... | Boston Scientific Corporation | LWP | ||
| Z-0646-2010 | Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF... | Zimmer GmbH | LXH | ||
| Z-1698-2011 | The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are... | Abbott Medical | GKZ | ||
| Z-0546-2010 | Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend... | Medtronic Powered Surgical Solutions | HBB | ||
| Z-0818-2013 | Class II | Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2"... | NAImco Inc dba Richmar Inc | GXY | |
| Z-0817-2013 | Class II | Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and... | NAImco Inc dba Richmar Inc | GXY | |
| Z-0816-2013 | Class II | Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2"... | NAImco Inc dba Richmar Inc | GXY | |
| Z-0815-2013 | Class II | Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454... | NAImco Inc dba Richmar Inc | GXY | |
| Z-1861-2011 | Stanley Bed-Check 90-Day LT Bed Sensormat, With 8 Ft. Cord, Model 74011, 5 mats per inner... | Securitas Healthcare LLC | KMI | ||
| Z-1860-2011 | Stanley Bed-Check 30-Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010, 10 mats per... | Securitas Healthcare LLC | KMI | ||
| Z-1859-2011 | Stanley Bed-Check 90-Day LT Bed Sensormat, With 5.5 Ft. Cord, Model 74001, 5 mats per... | Securitas Healthcare LLC | KMI | ||
| Z-1858-2011 | Stanley Bed-Check 30-Day IT Bed Sensormat, With 5.5 Ft. Cord, Model 74000, 10 mats per... | Securitas Healthcare LLC | KMI | ||
| Z-1857-2011 | Stanley Bed-Check 30-Day IT Chair Sensormat, With 8 Ft. Cord, Model 73010, 10 mats per... | Securitas Healthcare LLC | KMI | ||
| Z-1856-2011 | Stanley Bed-Check 90-Day LT Chair Sensormat, With 4 Ft. Cord, Model 73001, 5 mats per... | Securitas Healthcare LLC | KMI |