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-0420-2010 | The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System"... | Natus Medical Incorporated | LBI | ||
| Z-0749-2010 | RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number... | Abbott Vascular | NIM | ||
| Z-0062-2010 | Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT... | Philips North America LLC | MKJ | ||
| Z-0063-2010 | Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped... | Philips North America LLC | MKJ | ||
| Z-0896-2011 | Acuson Antares Ultrasound System Diagnostic Ultrasound system | Siemens Medical Solutions USA, Inc. | ITX | ||
| Z-0174-2010 | Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0165-2010 | * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT... | ConMed Corporation | GEI | ||
| Z-0119-2010 | Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear... | Cochlear Americas | MCM | ||
| Z-1495-2011 | PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the... | Bio-Rad Laboratories Inc. | JQW | ||
| Z-0271-2010 | Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0270-2010 | Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression. | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0524-2010 | Merit Medical systems, Inc, Convenience Kit REF/CAT no.: K09-07692 REVISION A , CUSTOM... | Merit Medical Systems, Inc. | MDM | ||
| Z-0523-2010 | Merit Medical Sysems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag... | Merit Medical Systems, Inc. | KZD | ||
| Z-0522-2010 | Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No... | Merit Medical Systems, Inc. | GES | ||
| Z-0521-2010 | Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device... | Merit Medical Systems, Inc. | KGZ | ||
| Z-0520-2010 | Merit Medical Systems, Inc. Medallion Syringe REF/CAT No.: MSS111-LB Indicated for use... | Merit Medical Systems, Inc. | FMF | ||
| Z-0519-2010 | Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035... | Merit Medical Systems, Inc. | DRE | ||
| Z-0518-2010 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT... | Merit Medical Systems, Inc. | DYB | ||
| Z-0517-2010 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT... | Merit Medical Systems, Inc. | DYB | ||
| Z-0516-2010 | Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220 | Merit Medical Systems, Inc. | DXT | ||
| Z-0515-2010 | Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with... | Merit Medical Systems, Inc. | DXT | ||
| Z-0514-2010 | Merit Advance Angiographic Needle label reading in part: MAJESTIK SERIES ANGIOGRAPHIC... | Merit Medical Systems, Inc. | DXT | ||
| Z-0513-2010 | Merit Medical Systems, Inc. Monarch Inflation Syringe CATALOG NUMBER IN2230 for... | Merit Medical Systems, Inc. | DXT | ||
| Z-0512-2010 | Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: MONARCH... | Merit Medical Systems, Inc. | DXT | ||
| Z-0511-2010 | Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/... | Merit Medical Systems, Inc. | DQO | ||
| Z-0510-2010 | Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12"... | Merit Medical Systems, Inc. | DQO | ||
| Z-0103-2010 | WA 1000 A/B Console Model: 900516x. | CooperSurgical, Inc. | GEH | ||
| Z-0102-2010 | WA 4000 Console Model: 900509x. | CooperSurgical, Inc. | GEH | ||
| Z-0101-2010 | WA 1000A with Blank Console Model: 900506x. | CooperSurgical, Inc. | GEH | ||
| Z-0100-2010 | Wallach LL100 Cryosurgical Freezer CO2 System Model: 900107. | CooperSurgical, Inc. | GEH | ||
| Z-0099-2010 | Wallach LL100 Cryosurgical Freezer No Connector CO2 System Model: 900047. | CooperSurgical, Inc. | GEH | ||
| Z-0098-2010 | Wallach LL100 Cryosurgical Freezer CO2 System Model: 900043. | CooperSurgical, Inc. | GEH | ||
| Z-0097-2010 | Wallach LL100 Cryosurgical Freezer Atom CO2 System Model: 900036. | CooperSurgical, Inc. | GEH | ||
| Z-0096-2010 | Wallach LL100 Cryosurgical Freezer Short Shaft CO2 System Model: 900034. | CooperSurgical, Inc. | GEH | ||
| Z-0095-2010 | Wallach LL100 Cryosurgical Freezer No Gas Fitting CO2 System Model: 900019x. | CooperSurgical, Inc. | GEH | ||
| Z-0094-2010 | Wallach LL50x Cryosurgical Freezer CO2 Unpinned Yoke System Model: 900010. | CooperSurgical, Inc. | GEH | ||
| Z-0093-2010 | Wallach LL50x Cryosurgical Freezer CO2 System Model: 900007. | CooperSurgical, Inc. | GEH | ||
| Z-0092-2010 | Wallach LL100 Cryosurgical Freezer CO2 System Model: 9000002X. | CooperSurgical, Inc. | GEH | ||
| Z-0865-2010 | i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer | Abbott Medical | JQP | ||
| Z-0197-2010 | Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120)... | Boston Scientific Corporation | DQY | ||
| Z-0196-2010 | Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100)... | Boston Scientific Corporation | DQY | ||
| Z-0195-2010 | Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080)... | Boston Scientific Corporation | DQY | ||
| Z-0194-2010 | Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060)... | Boston Scientific Corporation | DQY | ||
| Z-0091-2010 | Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 Model: 900000. | CooperSurgical, Inc. | GEH | ||
| Z-0978-2010 | BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of... | Becton Dickinson & Co | JTO | ||
| Z-0173-2010 | Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health &... | Ethicon, Inc | HET | ||
| Z-0181-2010 | Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for... | Organogenesis, Inc. | MGR | ||
| Z-0631-2010 | GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9... | GE Medical Systems Information Technologies, Inc. | DQA | ||
| Z-0193-2010 | Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog#... | LivaNova USA, Inc. | KFM | ||
| Z-0192-2010 | Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN... | LivaNova USA, Inc. | KFM |