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-1698-2012 | Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine... | Genesys Spine | MAX | ||
| Z-0924-2012 | VITROS ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS... | Ortho-Clinical Diagnostics, Inc. | KHO | ||
| Z-0923-2012 | VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi... | Ortho-Clinical Diagnostics, Inc. | KHO | ||
| Z-3097-2011 | Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc... | Encision, Inc. | GEI | ||
| Z-3096-2011 | Encision AEM Suction Irrigation Electrode, J-Hook, REF ES3884. Encision Inc., Boulder... | Encision, Inc. | GEI | ||
| Z-3095-2011 | Encision AEM Suction Irrigation Electrode, L-Hook, REF ES3883, Encision Inc., Boulder... | Encision, Inc. | GEI | ||
| Z-3094-2011 | Encision AEM Suction Irrigation Electrode, Spatula, REF ES3882, Encision Inc... | Encision, Inc. | GEI | ||
| Z-3093-2011 | Encision AEM Suction Irrigation Electrode, L-Diamond, REF ES3881. Encision Inc... | Encision, Inc. | GEI | ||
| Z-0133-2012 | GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray... | GE Healthcare | MQB | ||
| Z-1044-2012 | STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a... | Diagnostica Stago, Inc. | GGN | ||
| Z-0868-2012 | Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in... | Lin-Zhi International Inc | DKB | ||
| Z-0138-2012 | Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 Stryker EDS... | STRYKER Communications, Inc. | GCJ | ||
| Z-0137-2012 | Visum LED Surgical Lights/ Visum Halogen Surgical Lights. Stryker Communications, 1410... | STRYKER Communications, Inc. | FSY | ||
| Z-0136-2012 | SwitchPoint Infinity Control System Stryker Communications, 1410 Lakeside Parkway, #... | STRYKER Communications, Inc. | FSY | ||
| Z-0016-2012 | DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer... | Deroyal Industries, Inc. Lafollette | OFD | ||
| Z-0015-2012 | Custom anesthesia kits labeled as follows: (1) DeRoyal (R) Adult Exp Anesthesia... | Deroyal Industries, Inc. Lafollette | OGD | ||
| Z-3210-2011 | Game Ready Professional Therapy System, a cryotherapy device. Intended to treat... | Coolsystems, Inc. | IRP | ||
| Z-0340-2012 | Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo... | Atom Medical Corporation | FMZ | ||
| Z-0339-2012 | Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo... | Atom Medical Corporation | FMZ | ||
| Z-0338-2012 | Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo... | Atom Medical Corporation | FMZ | ||
| Z-0337-2012 | Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo... | Atom Medical Corporation | FMZ | ||
| Z-0421-2012 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage... | TORNIER Inc. | HRS | ||
| Z-2310-2012 | Class II | OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW... | Exactech, Inc. | JWH | |
| Z-0804-2012 | Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics... | Howmedica Osteonics Corp | LXH | ||
| Z-0044-2012 | AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES... | CooperVision, Inc. | LPL | ||
| Z-0145-2012 | MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number... | Merz North America, Inc. | LMH | ||
| Z-0012-2012 | Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX... | Biomet Microfixation | ECI | ||
| Z-3282-2011 | ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software... | GE Healthcare | LLZ | ||
| Z-2040-2014 | Class II | ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R... | Codan US Corp. | FPA | |
| Z-1004-2012 | CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate... | Veridex, LLC | NQI | ||
| Z-0606-2012 | Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica... | Howmedica Osteonics Corp | NPJ | ||
| Z-0418-2012 | FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800... | Encore Medical, LP | JDI | ||
| Z-3260-2011 | Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP... | Lee Medical International Inc | FKG | ||
| Z-3171-2011 | DUET TRS 60 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with... | Medtronic, Inc. | GDW | ||
| Z-3170-2011 | DUET TRS 60 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with... | Medtronic, Inc. | GDW | ||
| Z-3169-2011 | DUET TRS 60 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with... | Medtronic, Inc. | GDW | ||
| Z-3168-2011 | DUET TRS 60 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with... | Medtronic, Inc. | GDW | ||
| Z-3167-2011 | DUET TRS 45 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with... | Medtronic, Inc. | GDW | ||
| Z-3166-2011 | DUET TRS 45 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with... | Medtronic, Inc. | GDW | ||
| Z-3165-2011 | DUET TRS 45 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with... | Medtronic, Inc. | GDW | ||
| Z-3164-2011 | DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with... | Medtronic, Inc. | GDW | ||
| Z-3276-2011 | LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare... | Baxter Healthcare Corporation | LHI | ||
| Z-2229-2012 | Class III | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for... | CliniSys, Inc | JQP | |
| Z-2147-2012 | Class II | CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use... | Linvatec Corporation | LXH | |
| Z-0139-2012 | Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or... | Picis Clinical Solutions, Inc. | NSX | ||
| Z-0184-2012 | Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection... | Greiner Bio-One North America, Inc. | JKA | ||
| Z-0037-2012 | LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart... | Boston Scientific Corporation | LWS | ||
| Z-0210-2012 | VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics... | LivaNova USA, Inc. | LYJ | ||
| Z-0040-2012 | Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with... | Worldwide Medical Technologies, LLC | IWJ | ||
| Z-3268-2011 | Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing... | Medrad, Inc. | LFR |