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-1240-2012 | Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access... | Siemens Healthcare Diagnostics Inc. | CIN | ||
| Z-1239-2012 | Access Ostase QC, Part Number: 37309. The Access Ostase QC is intended for monitoring... | Siemens Healthcare Diagnostics Inc. | JJX | ||
| Z-1238-2012 | Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access... | Siemens Healthcare Diagnostics Inc. | CIN | ||
| Z-0945-2012 | Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf... | Varian Medical Systems, Inc. | IYE | ||
| Z-0714-2012 | VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical... | Ortho-Clinical Diagnostics, Inc. | DHR | ||
| Z-0414-2012 | VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VC NT FRS... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0413-2012 | VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0412-2012 | VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, VenaCure... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0411-2012 | VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0410-2012 | VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0409-2012 | VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0408-2012 | VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0407-2012 | VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0406-2012 | VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0405-2012 | VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0404-2012 | VenaCure EVLT NeverTouch - FRS .018" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 25... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0403-2012 | VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0402-2012 | VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0401-2012 | VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0400-2012 | VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0292-2012 | Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave... | Abbott Medical | FPA | ||
| Z-0390-2012 | Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g... | Henry Schein, Inc. | EMA | ||
| Z-0302-2012 | Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0301-2012 | Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 Product Usage... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0300-2012 | Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray) Product... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1063-2018 | Class II | ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the... | Hyphen Biomed Sasu | LCO | |
| Z-1062-2018 | Class II | ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection... | Hyphen Biomed Sasu | LCO | |
| Z-0459-2012 | ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0451-2012 | Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve... | Sonoma Pharmaceuticals, Inc. | FRO | ||
| Z-0450-2012 | Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz. 99.999%... | Sonoma Pharmaceuticals, Inc. | FRO | ||
| Z-0449-2012 | Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger... | Sonoma Pharmaceuticals, Inc. | FRO | ||
| Z-0448-2012 | Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990... | Sonoma Pharmaceuticals, Inc. | FRO | ||
| Z-0802-2012 | BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS... | Medtronic, Inc. | GXY | ||
| Z-0508-2012 | Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy... | Depuy Orthopaedics Inc. | HXK | ||
| Z-0299-2012 | The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0298-2012 | The Terumo Advanced Perfusion System 1, Catalog Number 801763, System 1 Base, 110... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0913-2012 | Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light... | STRYKER Communications, Inc. | FSY | ||
| Z-0382-2012 | CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife... | Accuray Incorporated | IYE | ||
| Z-0463-2012 | Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962. | Smith & Nephew, Inc. | GEI | ||
| Z-1828-2012 | Class II | Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection... | ZimVie US Corp LLC | DZE | |
| Z-0870-2012 | Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents. | ZOLL Medical Corporation | BTL | ||
| Z-0641-2012 | LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured... | Medtronic, Inc. | GEI | ||
| Z-0640-2012 | LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO... | Medtronic, Inc. | GEI | ||
| Z-0291-2012 | ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8024, Provider... | Immunetech Corporation | JKA | ||
| Z-0290-2012 | ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8021, Screening... | Immunetech Corporation | JKA | ||
| Z-0289-2012 | ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8015, Screening... | Immunetech Corporation | JKA | ||
| Z-0288-2012 | ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider... | Immunetech Corporation | JKA | ||
| Z-0287-2012 | ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8013, Provider... | Immunetech Corporation | JKA | ||
| Z-0286-2012 | ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001; Individually... | Immunetech Corporation | JKA | ||
| Z-0250-2013 | Class II | Sunquest Laboratory, version 7.0 not available | CliniSys, Inc | JQP |