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-1541-2012 | Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT... | Terumo BCT, Ltd | KZE | ||
| Z-2564-2011 | Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to... | Elekta Limited | MUJ | ||
| Z-2595-2011 | XiO Radiation Treatment Planning System, XiO Release 4.0.2 and above Used to create... | Elekta Limited | MUJ | ||
| Z-0473-2011 | HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text... | Philips North America LLC | MKJ | ||
| Z-0472-2011 | HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text... | Philips North America LLC | MKJ | ||
| Z-0471-2011 | HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand... | Philips North America LLC | MKJ | ||
| Z-0470-2011 | HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand... | Philips North America LLC | MKJ | ||
| Z-2407-2011 | XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create... | Elekta Limited | MUJ | ||
| Z-2593-2011 | XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above Used to create... | Elekta Limited | MUJ | ||
| Z-1722-2011 | The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers... | Physio Control, Inc. | MKJ | ||
| Z-2116-2010 | PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the... | FUJIFILM SonoSite,Inc. | IYN | ||
| Z-2172-2010 | Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL)... | Abbott Medical | NRP | ||
| Z-1903-2010 | LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx... | Physio Control, Inc. | MKJ | ||
| Z-1142-2012 | Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item... | Sybron Dental Specialties, Inc. | KLE | ||
| Z-2148-2010 | Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile... | Baxter Corporation Englewood | KPE | ||
| Z-2147-2010 | Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag... | Baxter Corporation Englewood | KPE | ||
| Z-2146-2010 | Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724... | Baxter Corporation Englewood | KPE | ||
| Z-2145-2010 | Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938... | Baxter Corporation Englewood | KPE | ||
| Z-2144-2010 | Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber... | Baxter Corporation Englewood | KPE | ||
| Z-2143-2010 | Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation. | Baxter Corporation Englewood | KPE | ||
| Z-2142-2010 | Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation. | Baxter Corporation Englewood | KPE | ||
| Z-2141-2010 | Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation. | Baxter Corporation Englewood | KPE | ||
| Z-2140-2010 | Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation. | Baxter Corporation Englewood | KPE | ||
| Z-2139-2010 | Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation. | Baxter Corporation Englewood | KPE | ||
| Z-2138-2010 | Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation. | Baxter Corporation Englewood | KPE | ||
| Z-2137-2010 | Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation. | Baxter Corporation Englewood | KPE | ||
| Z-2067-2010 | GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL... | GE Healthcare | JQP | ||
| Z-1889-2010 | 22ga x 1" Right Angle Huber Needle This product is a small gauge needle intended for... | Multi-Med, Inc. | FMI | ||
| Z-1888-2010 | 22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single... | Multi-Med, Inc. | FMI | ||
| Z-2014-2010 | Microstream O2/CO2 NASAL FILTERLINE ADULT LONG O2 CONN 100UN Part Number: 010343... | Oridion Medical 1987 Ltd. | cck | ||
| Z-2013-2010 | Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN Part Number: 010341 010341 Part... | Oridion Medical 1987 Ltd. | cck | ||
| Z-2012-2010 | Microstream FILTERLINE SET ADU/PED 25UN Part Number: XS04620-01 Oridion... | Oridion Medical 1987 Ltd. | cck | ||
| Z-2011-2010 | Microstream FILTERLINE H SET ADULT/PEDIATRIC 100 UN Part Number: 010580-01 | Oridion Medical 1987 Ltd. | cck | ||
| Z-2010-2010 | Microstream FILTERLINE SET ADULT/PEDIATRIC 100 UN Part Number: 010579-01 | Oridion Medical 1987 Ltd. | cck | ||
| Z-2009-2010 | Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625 | Oridion Medical 1987 Ltd. | cck | ||
| Z-2008-2010 | Microstream SMART CAPNOLINE H PLUS O2 ADU/INT 25UN Part Number: 010433 | Oridion Medical 1987 Ltd. | cck | ||
| Z-2007-2010 | Microstream SMART CAPNOLINE PLUS O2 100UN Part Number: 010210 Oridion... | Oridion Medical 1987 Ltd. | cck | ||
| Z-2006-2010 | Microstream SMART CAPNOLINE PLUS 100 UN Part Number: 010209 Oridion... | Oridion Medical 1987 Ltd. | cck | ||
| Z-2005-2010 | Microstream SMART CAPNOLINE PLUS O2 LONG ADU/INT 25UN Part Number: 009826 | Oridion Medical 1987 Ltd. | cck | ||
| Z-2004-2010 | Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion... | Oridion Medical 1987 Ltd. | cck | ||
| Z-2003-2010 | Microstream SMART CAPNOLINE PLUS ADU/INT 25UN Part Number: 009818 Oridion... | Oridion Medical 1987 Ltd. | cck | ||
| Z-2002-2010 | Microstream CAPNOLINE H O2 ADULT 25UN Part Number: 008180 | Oridion Medical 1987 Ltd. | cck | ||
| Z-2001-2010 | Microstream CAPNOLINE H ADULT 25UN Part Number: 008177 | Oridion Medical 1987 Ltd. | cck | ||
| Z-2000-2010 | Microstream NIVLINE ADULT 25UN Part Number: 008174 | Oridion Medical 1987 Ltd. | CCK | ||
| Z-1999-2010 | Microstream O2/CO2 NASAL FILTERLINE ADULT 25UN Part Number: 006912 | Oridion Medical 1987 Ltd. | CCK | ||
| Z-2109-2010 | MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm... | Microtek Medical LLC | FYD | ||
| Z-0106-2011 | Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and... | Varian Medical Systems, Inc. | IYE | ||
| Z-0015-2011 | Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with... | Boston Scientific Corporation | FGE | ||
| Z-2066-2010 | Hemashield Gold Woven and Knitted Double Vascular Grafts. | Maquet Cardiovascular LLC | MAL | ||
| Z-2065-2010 | Hemashield Platinum Woven Double Velour TAAA Vascular Grafts. | Maquet Cardiovascular LLC | MAL |