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-0994-2009 | Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable... | LivaNova USA, Inc. | LYJ | ||
| Z-1364-2008 | BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA003, 3.0mm, BioMet 3i , Palm Beach... | ZimVie US Corp LLC | DZE | ||
| Z-1363-2008 | BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach... | ZimVie US Corp LLC | DZE | ||
| Z-1538-2008 | Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number... | Stryker Corp. | MBI | ||
| Z-1537-2008 | Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number... | Stryker Corp. | MBI | ||
| Z-1536-2008 | Stryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025 Used for... | Stryker Corp. | HWC | ||
| Z-1535-2008 | Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation... | Stryker Corp. | HWC | ||
| Z-1534-2008 | Stryker Peek Intraline Anchor, 5.5 mm with Needles, Model number 3910-400-015 Used for... | Stryker Corp. | HWC | ||
| Z-1533-2008 | Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010 Used for tissue fixation... | Stryker Corp. | HWC | ||
| Z-1360-2008 | Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic... | Horiba Instruments Incorporated | CJE | ||
| Z-1305-2008 | Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in... | Boston Scientific Corporation | DQY | ||
| Z-1304-2008 | Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in... | Boston Scientific Corporation | DQY | ||
| Z-1303-2008 | Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in... | Boston Scientific Corporation | DQY | ||
| Z-1302-2008 | Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm, .070 in... | Boston Scientific Corporation | DQY | ||
| Z-1301-2008 | Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in... | Boston Scientific Corporation | DQY | ||
| Z-1300-2008 | Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal... | Boston Scientific Corporation | DQY | ||
| Z-1359-2008 | Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos... | Horiba Instruments Incorporated | CJE | ||
| Z-1358-2008 | Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos... | Horiba Instruments Incorporated | CJE | ||
| Z-1357-2008 | Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe... | Horiba Instruments Incorporated | CJE | ||
| Z-1356-2008 | Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe... | Horiba Instruments Incorporated | CJE | ||
| Z-1355-2008 | Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe... | Horiba Instruments Incorporated | CJE | ||
| Z-1354-2008 | Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro... | Horiba Instruments Incorporated | CJE | ||
| Z-1353-2008 | Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450, A7516-625... | Horiba Instruments Incorporated | CJE | ||
| Z-1886-2008 | Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896... | Philips North America LLC | IZW | ||
| Z-1969-2010 | Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and... | Microline Surgical, Inc | GEI | ||
| Z-1365-2008 | BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32... | ZimVie US Corp LLC | NHA | ||
| Z-1556-2011 | PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation... | Elekta Limited | MUJ | ||
| Z-1315-2008 | Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number... | Draeger, Inc. | BSZ | ||
| Z-2046-2009 | Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile... | Terumo Cardiovascular Systems Corporation | DTS | ||
| Z-1903-2008 | IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling... | Medtronic Neuromodulation | LKK | ||
| Z-1240-2008 | LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc... | Diasorin Inc. | MRG | ||
| Z-1689-2008 | Stryker Medical Epic II Critical Care Bed, 230 V, Stryker Medical, Portage, MI.; Model... | Stryker Medical | FNL | ||
| Z-1688-2008 | Stryker Medical Secure II Med/Surg Bed, 230 V, Stryker Medical, Portage, MI.; Model 3221... | Stryker Medical | FNL | ||
| Z-1687-2008 | Stryker Medical Epic II Critical Care Bed with Zoom Drive System, 115 V, Stryker Medical... | Stryker Medical | FNL | ||
| Z-1686-2008 | Stryker Medical Epic II Critical Care Bed, 115 V, Stryker Medical, Portage, MI.; Model... | Stryker Medical | FNL | ||
| Z-1685-2008 | Stryker Medical Secure II Med/Surg Bed, 115 V, Stryker Medical, Portage, MI.; Model 3002. | Stryker Medical | FNL | ||
| Z-1458-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number... | Zimmer GmbH | GCY | ||
| Z-1457-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number... | Zimmer GmbH | GCY | ||
| Z-1456-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number... | Zimmer GmbH | GCY | ||
| Z-1455-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF... | Zimmer GmbH | GCY | ||
| Z-1454-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF... | Zimmer GmbH | GCY | ||
| Z-1453-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF... | Zimmer GmbH | GCY | ||
| Z-1452-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF... | Zimmer GmbH | GCY | ||
| Z-1451-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF... | Zimmer GmbH | GCY | ||
| Z-1450-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF... | Zimmer GmbH | GCY | ||
| Z-1449-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF... | Zimmer GmbH | GCY | ||
| Z-1657-2008 | ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number... | ArthroCare Corporation | HRX | ||
| Z-1448-2008 | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF... | Zimmer GmbH | GCY | ||
| Z-1053-2008 | Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA... | Draeger, Inc. | FMZ | ||
| Z-1052-2008 | Draeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical... | Draeger, Inc. | FMZ |