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-2469-2008 | Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group... | LivaNova USA, Inc. | DTZ | ||
| Z-2191-2010 | SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th... | FUJIFILM SonoSite,Inc. | IYO | ||
| Z-0162-2009 | GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL... | Smith & Nephew, Inc. | BTA | ||
| Z-0432-2011 | Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog... | Philips North America LLC | MKJ | ||
| Z-2451-2008 | DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included... | Smith & Nephew, Inc. | HRX | ||
| Z-2450-2008 | DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included... | Smith & Nephew, Inc. | HRX | ||
| Z-2449-2008 | DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included... | Smith & Nephew, Inc. | HRX | ||
| Z-2448-2008 | DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included... | Smith & Nephew, Inc. | HRX | ||
| Z-1435-2009 | WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide... | Innovative Neurotronics, Inc. | GZI | ||
| Z-0867-2009 | REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9")... | Biomet Microfixation | |||
| Z-0866-2009 | REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C... | Biomet Microfixation | |||
| Z-0865-2009 | REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit, 1... | Biomet Microfixation | |||
| Z-0864-2009 | REF: 915-1006 Lactosorb System, Lacto Endobrow Lift Complete, 10X13CM. (3.75X5.25")... | Biomet Microfixation | |||
| Z-0287-2009 | NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk... | Boston Scientific Corporation | DTZ | ||
| Z-1900-2009 | ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by... | ArthroCare Corporation | GEI | ||
| Z-2468-2008 | Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-2198-2008 | Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in... | Greiner Bio-One North America, Inc. | FMI | ||
| Z-2453-2008 | SOMATOM Emotion 16. Computed tomography X-ray system | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-2452-2008 | SOMATOM Emotion 6. Computed tomography X-ray system | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-2447-2008 | Caption Disposable Platelet Concentrator Kit, Ref 71178202, 1 each, Sterile, Smith &... | Smith & Nephew, Inc. | FMF | ||
| Z-2446-2008 | Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith &... | Smith & Nephew, Inc. | FMF | ||
| Z-0295-2012 | GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF... | Varian Medical Systems, Inc. | JAQ | ||
| Z-0294-2009 | Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain... | Animas Corp. | LZG | ||
| Z-0293-2009 | Battery Caps used with Animas IR1200 Insulin Pump. The pump is used to help maintain... | Animas Corp. | LZG | ||
| Z-0292-2009 | Battery Caps used with Animas 2020 Insulin Pump. The pump is used to help maintain blood... | Animas Corp. | LZG | ||
| Z-0291-2009 | Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help... | Animas Corp. | LZG | ||
| Z-0283-2009 | One Touch Ping Glucose Monitoring System Combines the functionality of OneTouch(R) Ping... | Animas Corp. | LZG | ||
| Z-0290-2009 | Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used... | Animas Corp. | LZG | ||
| Z-0019-2009 | Medline Latex Free Mom/Baby Admit Kit - LF; a single patient prescription procedure pack... | MEDLINE INDUSTRIES, LP - Northfield | OHM | ||
| Z-0018-2009 | Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack... | MEDLINE INDUSTRIES, LP - Northfield | OHM | ||
| Z-0017-2009 | Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure... | MEDLINE INDUSTRIES, LP - Northfield | OHM | ||
| Z-0016-2009 | Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack... | MEDLINE INDUSTRIES, LP - Northfield | OHM | ||
| Z-2462-2008 | Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724... | STERIS Corporation | MED | ||
| Z-2466-2008 | FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449... | Encore Medical, LP | JWH | ||
| Z-0015-2009 | Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient... | MEDLINE INDUSTRIES, LP - Northfield | OHM | ||
| Z-0173-2009 | IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of... | Immunodiagnostic Systems Ltd. | MRG | ||
| Z-2250-2009 | B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr | Halyard Health | FMF | ||
| Z-2249-2009 | B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2... | Halyard Health | FMF | ||
| Z-0816-2009 | King Systems 72" Universal Flex2 Extension Kit, 50 per case, King Systems Corporation... | King Systems Corporation. | CAI | ||
| Z-0815-2009 | King Systems 37" Universal Flex2 Extension Kit, 50 per case, King Systems Corporation... | King Systems Corporation. | CAI | ||
| Z-0814-2009 | King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case, King... | King Systems Corporation. | CAI | ||
| Z-0813-2009 | King Systems Universal Flex2 Breathing Circuit and Pack Kit, Latex Free, 50 per case... | King Systems Corporation. | CAI | ||
| Z-0812-2009 | King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case, King... | King Systems Corporation. | CAI | ||
| Z-0811-2009 | King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case, King... | King Systems Corporation. | CAI | ||
| Z-0810-2009 | King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case, King... | King Systems Corporation. | CAI | ||
| Z-0809-2009 | King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case, King... | King Systems Corporation. | CAI | ||
| Z-0808-2009 | King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case, King... | King Systems Corporation. | CAI | ||
| Z-0807-2009 | King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case, King... | King Systems Corporation. | CAI | ||
| Z-0806-2009 | King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case, King... | King Systems Corporation. | CAI | ||
| Z-0805-2009 | King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case, King... | King Systems Corporation. | CAI |