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-1896-2010 | Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips... | Respironics, Inc. | CBK | ||
| Z-2238-2010 | Innova 2000, manufactured by GE Medical Systems, SCS | GE Healthcare | MQB | ||
| Z-2617-2010 | Cardiovascular Procedure Kit X-Coated H/L pack with Cardioplegia, Item # 70067-03 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2616-2010 | Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component... | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2615-2010 | Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part... | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2614-2010 | Cardiovascular Procedure Kit X-Coated Pump and Table Pack, Item #71552 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2613-2010 | Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2612-2010 | Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2611-2010 | Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2610-2010 | Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2315-2010 | E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a... | Advandx, Inc. | OAH | ||
| Z-2163-2010 | Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N... | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2162-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2161-2010 | Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2160-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2159-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2158-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1... | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2157-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2156-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PP | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2155-2010 | Terumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N 71733 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2154-2010 | Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2153-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2152-2010 | Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2151-2010 | Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP &... | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2150-2010 | Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N... | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2149-2010 | Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937 | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-2798-2011 | Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack"... | Terumo Medical Corp. | FMI | ||
| Z-0881-2011 | Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston... | Boston Scientific Corporation | DQX | ||
| Z-0880-2011 | Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip; Boston... | Boston Scientific Corporation | DQX | ||
| Z-0879-2011 | Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 45 cm tip; Boston... | Boston Scientific Corporation | DQX | ||
| Z-0878-2011 | Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston... | Boston Scientific Corporation | DQX | ||
| Z-0877-2011 | Boston Scientific brand Synchro.14" Guide Wire, 45 cm, tip; Boston Scientific... | Boston Scientific Corporation | DQX | ||
| Z-0876-2011 | Boston Scientific brand Synchro.14" Guide Wire, 35 cm, tip; Boston Scientific... | Boston Scientific Corporation | DQX | ||
| Z-0875-2011 | Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped; Boston... | Boston Scientific Corporation | DQX | ||
| Z-0874-2011 | Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard; Boston Scientific... | Boston Scientific Corporation | DQX | ||
| Z-0873-2011 | Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped; Boston... | Boston Scientific Corporation | DQX | ||
| Z-0872-2011 | Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific... | Boston Scientific Corporation | DQX | ||
| Z-0871-2011 | Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped; Boston... | Boston Scientific Corporation | DQX | ||
| Z-0870-2011 | Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft; Boston Scientific... | Boston Scientific Corporation | DQX | ||
| Z-0869-2011 | Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped; Boston... | Boston Scientific Corporation | DQX | ||
| Z-0868-2011 | Boston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft. Boston Scientific; Made... | Boston Scientific Corporation | DQX | ||
| Z-2292-2010 | Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer | Integrated Orbital Implants Inc | HPZ | ||
| Z-2579-2010 | Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in... | Ela Medical, Inc. | NIK | ||
| Z-2212-2010 | DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36... | Wright Medical Technology Inc | JDL | ||
| Z-2188-2010 | CLAW HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw... | Wright Medical Technology Inc | HRS | ||
| Z-0039-2011 | The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in... | Cenorin, LLC | LDS | ||
| Z-0038-2011 | The HLD SYSTEM 540HT is a Medical Device Cleaning and High Level Disinfection Systems... | Cenorin, LLC | LDS | ||
| Z-0037-2011 | HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems... | Cenorin, LLC | LDS | ||
| Z-2274-2010 | Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use... | Arrow International LLC (subsidiary of Teleflex Incorporated) | KGZ | ||
| Z-2309-2010 | Mitek VAPR Temperature Control Electrode (integrated Product Code: 227252 The VAPR... | DePuy Mitek, Inc. | GEI |