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-0130-06 | Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and... | Baxter Healthcare Corporation | FRN | ||
| Z-0864-05 | Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part... | Zimmer GmbH | LXH | ||
| Z-0604-05 | Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter... | Medtronic, Inc. | NIK | ||
| Z-0603-05 | Medtronic InSync III Protect, model 7285 Dual Chamber Implantable Cardioverter... | Medtronic, Inc. | NIK | ||
| Z-0602-05 | Medtronic InSync III Marquis, model 7279 Dual Chamber Implantable Cardioverter... | Medtronic, Inc. | NIK | ||
| Z-0601-05 | Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator... | Medtronic, Inc. | LWS | ||
| Z-0600-05 | Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator... | Medtronic, Inc. | NIK | ||
| Z-0599-05 | Medtronic Marquis DR, model 7274 Dual Chamber Implantable Cardioverter Defibrillator... | Medtronic, Inc. | LWS | ||
| Z-0598-05 | Medtronic Maximo VR, model 7232 Single Chamber Implantable Cardioverter Defibrillator... | Medtronic, Inc. | LWS | ||
| Z-0597-05 | Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator... | Medtronic, Inc. | LWS | ||
| Z-1382-2008 | Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint... | Howmedica Osteonics Corp | JWH | ||
| Z-1381-2008 | Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial... | Howmedica Osteonics Corp | JWH | ||
| Z-0786-05 | Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is... | Stryker Corp. | HRX | ||
| Z-0563-05 | Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1 | Medtronic Navigation, Inc | GEI | ||
| Z-0668-05 | MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by... | Siemens Healthcare Diagnostics Inc. | LON | ||
| Z-0561-05 | LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml , Length 80 cm... | LeMaitre Vascular Inc. | DXE | ||
| Z-0560-05 | LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm... | LeMaitre Vascular Inc. | DXE | ||
| Z-0559-05 | LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm... | LeMaitre Vascular Inc. | DXE | ||
| Z-0558-05 | LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm... | LeMaitre Vascular Inc. | DXE | ||
| Z-0557-05 | LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm... | LeMaitre Vascular Inc. | DXE | ||
| Z-0563-06 | Centrifuge Model CF-6 with lid lock. (Block Model number OCT-VI). Units are distributed... | Cygnus, LLC | JQC | ||
| Z-0777-05 | Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system... | Varian Medical Systems, Inc. | IYE | ||
| Z-0542-05 | RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test... | UPS Supply Chain Solutions, Inc. | |||
| Z-0544-05 | SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons... | Bausch & Lomb Incorporated | LPL | ||
| Z-0587-05 | BD Nexiva Closed IV Catheter System, 24 gauge | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0586-05 | BD Nexiva Closed IV Catheter System, 22 gauge | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0585-05 | BD Nexiva Closed IV Catheter System, 20 gauge | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0584-05 | BD Nexiva Closed IV Catheter System, 18 gauge | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0785-05 | Sunrise Hoyer Advance Patient lifts | Sunrise Medical, Inc. | FSA | ||
| Z-0562-05 | Lifepak 500 AED. | Physio Control, Inc. | MKJ | ||
| Z-1437-06 | TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen... | Radiometer America, Inc | KLK | ||
| Z-0930-2007 | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0929-2007 | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1314-06 | D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer. | Radiometer America, Inc | CGZ | ||
| Z-0959-05 | Spectre brand AC wall adapter to be used with ProControl 2 or ProHand battery powered... | Motion Control, Inc. | IQZ | ||
| Z-0679-05 | Platen, Catalog # 301-124, is a mechanism used to lock or hold the fill tube in place as... | Spineology, Inc. | LXH | ||
| Z-0678-05 | Fill Tube,straight, Catalog # 300-1001, is used for the delivery of granular autograft... | Spineology, Inc. | LXH | ||
| Z-0677-05 | Fill Tube,diverted, Catalog # 300-1002, is used for the delivery of granular autograft... | Spineology, Inc. | LXH | ||
| Z-0567-05 | Sterile Empty Vials for Allergenic Extracts, 100ml size | Greer Laboratories Inc | JKA | ||
| Z-0711-05 | Stealth Station Cranial Application v.4.5 | Medtronic Navigation, Inc | HAW | ||
| Z-0707-05 | Voyager RX Coronary Dilatation Catheter | Abbott Vascular | MAF | ||
| Z-0844-05 | Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal... | AMF Support Surfaces Inc | DWJ | ||
| Z-1404-05 | Radiomat Lightweight Cassettes | AGFA Healthcare Corp. | IXA | ||
| Z-0546-05 | Sodium Chloride Injection USP, manufactured by IV Flush LLC | IV Flush LLC | FOZ | ||
| Z-0545-05 | Heparin Lock Flush Solution, manufactured by IV Flush LLC | IV Flush LLC | FOZ | ||
| Z-0704-2007 | InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating... | GE Healthcare | LLZ | ||
| Z-1865-2008 | Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw... | Howmedica Osteonics Corp | KTT | ||
| Z-0802-05 | Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable... | Ela Medical, Inc. | LWS | ||
| Z-0801-05 | Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable... | Ela Medical, Inc. | LWS | ||
| Z-0659-05 | Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN... | Bio-Rad Laboratories Inc. | NOM |