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-2597-2010 | 7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile, BIOMET... | Zimmer GmbH | LXH | ||
| Z-2240-2010 | PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI... | Medtronic Navigation, Inc | LNH | ||
| Z-2190-2010 | Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working... | Spectranetics Corp. | DXE | ||
| Z-2447-2010 | PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | DXZ | ||
| Z-2444-2010 | St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE 203H / Model... | Osypka Medical GmbH | DTE | ||
| Z-3051-2011 | "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE... | Bio-Rad Laboratories Inc. | DHN | ||
| Z-2100-2010 | 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's... | AGFA Healthcare Corp. | MQB | ||
| Z-2443-2010 | Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085... | Osypka Medical GmbH | DTE | ||
| Z-1568-2011 | Polycarbonate prescription single vision lenses for use in sport goggles. To be worn by a... | Luxottica Optical Manufacturing | HQG | ||
| Z-0168-2011 | Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to... | Volcano Corporation | IYO | ||
| Z-1523-2011 | Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2355-2010 | Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The... | Siemens Healthcare Diagnostics Inc. | JNL | ||
| Z-2193-2010 | Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San... | Stryker Corp. | GEI | ||
| Z-2653-2010 | SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920 | Siemens Healthcare Diagnostics Inc. | DEW | ||
| Z-2182-2010 | St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max... | Abbott Medical | DYB | ||
| Z-2181-2010 | St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max... | Abbott Medical | DYB | ||
| Z-2180-2010 | St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max... | Abbott Medical | DYB | ||
| Z-2179-2010 | St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max... | Abbott Medical | DYB | ||
| Z-2178-2010 | St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max... | Abbott Medical | DYB | ||
| Z-2244-2010 | 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003. | Encore Medical, LP | JWH | ||
| Z-2199-2010 | PERI-LOC, 2.0 MM X 228 MM, K-WIRE W/TROCAR POINT, CO-CR, REF 71173361, QTY: (6), STERILE... | Smith & Nephew, Inc. | HTY | ||
| Z-2198-2010 | CERCLAGE WIRE, 0.8 MM DIA. X 200 MM LENGTH, SST, REF 71163008, QTY: (6), STERILE R, CE... | Smith & Nephew, Inc. | JDQ | ||
| Z-2197-2010 | CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE... | Smith & Nephew, Inc. | JDQ | ||
| Z-2106-2010 | Merit Laureate Hydrophylic Guide Wire, Straight Stiff Shaft, Made in Ireland, CAT No... | Merit Medical Systems, Inc. | DQX | ||
| Z-2105-2010 | Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No... | Merit Medical Systems, Inc. | DQX | ||
| Z-2104-2010 | Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX... | Merit Medical Systems, Inc. | DQX | ||
| Z-2103-2010 | Merit Laureate Hydrophylic Guide Wire, Straight, Made In Ireland, CAT No: LWSTFS35180... | Merit Medical Systems, Inc. | DQX | ||
| Z-2102-2010 | Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No... | Merit Medical Systems, Inc. | DQX | ||
| Z-2101-2010 | Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180... | Merit Medical Systems, Inc. | DQX | ||
| Z-2202-2010 | Philips Intellivue Patient Monitor Model MP70 (M8007A) | Philips North America LLC | MHX | ||
| Z-2201-2010 | Philips Intellivue Patient Monitor Model MP60 (M8005A) | Philips North America LLC | MHX | ||
| Z-0842-2012 | Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04... | Terumo Cardiovascular Systems Corporation | DTZ | ||
| Z-0160-2011 | Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences... | Edwards Lifesciences LLC | DXG | ||
| Z-2392-2010 | BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25") (L), STAINLESS... | Biomet Microfixation | GEN | ||
| Z-2200-2010 | International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls... | Accriva Diagnostics, Inc. | GGN | ||
| Z-2111-2010 | Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm)... | Medtronic, Inc. | GDF | ||
| Z-2211-2010 | DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and... | GE Healthcare | MSX | ||
| Z-2779-2011 | Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT... | Biomet Microfixation | KBW | ||
| Z-2415-2011 | Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve... | Terumo Medical Corp. | DYB | ||
| Z-0822-2011 | BD Beaver Slit Blade 3.0mm Straight Part Number: 375521 The BD Beaver Slit Blade is used... | BD Medical Systems | |||
| Z-0306-2011 | B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4... | B Braun Medical Inc | LHI | ||
| Z-0305-2011 | B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4... | B Braun Medical Inc | LHI | ||
| Z-0612-2011 | Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed... | Bio-Rad Laboratories Inc. | LKJ | ||
| Z-2110-2010 | RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and... | Accriva Diagnostics, Inc. | KFF | ||
| Z-2113-2010 | BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court... | GE Healthcare | BSZ | ||
| Z-2417-2011 | Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst... | Terumo Medical Corp. | DYB | ||
| Z-2416-2011 | Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve... | Terumo Medical Corp. | DYB | ||
| Z-2714-2011 | SoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008... | SCC Soft Computer | LNX | ||
| Z-1393-2011 | Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to... | Advanced Sterilization Products | KCT | ||
| Z-1249-2011 | Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model... | Varian Medical Systems, Inc. | IYE |