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-2228-2011 | Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R)... | Deroyal Industries, Inc. Lafollette | LRP | ||
| Z-2105-2011 | Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and... | InterX Technologies | GZJ | ||
| Z-2013-2011 | Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5... | DeRoyal Industries, Inc. | KMJ | ||
| Z-1957-2011 | Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy. | Varian Medical Systems, Inc. | IYE | ||
| Z-1577-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10)... | Remington Medical | KNW | ||
| Z-1576-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10)... | Remington Medical | KNW | ||
| Z-1575-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm... | Remington Medical | KNW | ||
| Z-1574-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm... | Remington Medical | KNW | ||
| Z-1573-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm... | Remington Medical | KNW | ||
| Z-1609-2011 | Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions... | Philips North America LLC | MKJ | ||
| Z-1907-2011 | 8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-2041-2011 | Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit... | Gendex Corp. | EHD | ||
| Z-2040-2011 | Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer... | Gendex Corp. | EHD | ||
| Z-0934-2013 | Class II | GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray... | GE Healthcare | MQB | |
| Z-0648-2012 | Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic... | Boston Scientific Corporation | FGE | ||
| Z-0647-2012 | Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic... | Boston Scientific Corporation | FGE | ||
| Z-0047-2012 | PERPOS Driver; Catalog # 6112 Interventional Spine, Inc. A cannulated, driver to be used... | Interventional Spine, Inc. | HXX | ||
| Z-0046-2012 | Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. Interventional Spine... | Interventional Spine, Inc. | HXX | ||
| Z-0045-2012 | PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. Interventional Spine... | Interventional Spine, Inc. | HXX | ||
| Z-1554-2011 | Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Large Size... | MEDLINE INDUSTRIES, LP - Northfield | OIG | ||
| Z-1553-2011 | Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium... | MEDLINE INDUSTRIES, LP - Northfield | OIG | ||
| Z-1830-2011 | Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266... | Stryker Corp. | HRX | ||
| Z-1829-2011 | Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265... | Stryker Corp. | HRX | ||
| Z-1865-2011 | Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up... | Xoft Inc. | IXI | ||
| Z-1221-2011 | Hill-Rom TotalCare Bariatric Bed, P1840, Hill-Rom, Batesville, IN. TheTotalCare Bed... | Hill-Rom Inc. | FNL | ||
| Z-1220-2011 | Hill-Rom TotalCare Bed, P1900, Hill-Rom, Batesville, IN. TheTotalCare Bed System is... | Hill-Rom Inc. | FNL | ||
| Z-0915-2012 | Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The... | Sybron Dental Specialties, Inc. | MZW | ||
| Z-1497-2011 | High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx... | Ethicon, Inc | KGX | ||
| Z-1496-2011 | Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc. | Ethicon, Inc | KGX | ||
| Z-1520-2011 | VCare Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged... | ConMed Corporation | L | ||
| Z-0270-2013 | Class II | AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC... | Primus Medical LLC | FNL | |
| Z-3035-2011 | Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon... | Mckesson Information Solutions, LLC | LLZ | ||
| Z-1610-2011 | Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2... | ConvaTec Limited | EXB | ||
| Z-2067-2011 | Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA)... | Therakos Inc | LNR | ||
| Z-1976-2011 | SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One... | CIBA Vision Puerto Rico, Inc. | LPL | ||
| Z-1956-2011 | Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology... | Siemens Healthcare Diagnostics Inc. | GKL | ||
| Z-1955-2011 | Coulter LH500 Series System The COULTER LH 500 Analyzer is a quantitative, automated... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1954-2011 | Coulter LH780 Analyzer The COULTER LH 750 Hematology Analyzer is a quantitative... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1953-2011 | Coulter LH750 Analyzer The COULTER LH 750 Hematology Analyzer is a quantitative... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1677-2011 | OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for... | Biostructures, LLC | MQV | ||
| Z-1899-2011 | 2380 MINI Hand-Held Tube Sealer Power Source (including a 23802000 Battery Pack) The... | Haemonetics Corporation | KSD | ||
| Z-0833-2012 | GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory... | GE Healthcare | RCE | ||
| Z-2442-2012 | Class II | Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm... | Cordis US Corp. | LOX | |
| Z-2441-2012 | Class II | Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon... | Cordis US Corp. | LOX | |
| Z-1746-2011 | Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living... | Organogenesis, Inc. | MGR | ||
| Z-1611-2011 | MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C... | STRYKER Communications, Inc. | |||
| Z-1594-2011 | ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850... | Zimmer GmbH | KWA | ||
| Z-1667-2011 | Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource... | Medtronic, Inc. | LRO | ||
| Z-1738-2011 | TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro... | Haemoscope Division of Haemonetics Corp | JPA | ||
| Z-1522-2011 | GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use... | GE Healthcare | MHX |