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-1783-2017 | Class II | Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1691-2017 | Class II | Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM... | Highridge Medical, LLC | MAX | |
| Z-0321-2018 | Class II | UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z... | King Systems Corporation. | CAH | |
| Z-3070-2017 | Class II | Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model... | Canon Medical Systems USA, Inc. | OWB | |
| Z-1895-2017 | Class II | Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff... | Richard-Allan Scientific LLC | HYF | |
| Z-1851-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1850-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1849-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1848-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1847-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1846-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1845-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1844-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1843-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1842-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1841-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1840-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1839-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1838-2017 | Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX... | Smith & Nephew, Inc. | GFG | |
| Z-1729-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1728-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1727-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1726-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1725-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1724-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1723-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1722-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1721-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1720-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1719-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1718-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1717-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1716-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1715-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1714-2017 | Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da... | Intuitive Surgical, Inc. | NAY | |
| Z-1865-2017 | Class II | Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies... | Avid Medical, Inc. a Medical Action Ind. Company 305 | OKV | |
| Z-2320-2017 | Class II | NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw... | Nexstim Inc. | GWF | |
| Z-2319-2017 | Class II | Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain... | Nexstim Inc. | GWF | |
| Z-1899-2017 | Class II | Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and... | Roche Diabetes Care, Inc. | NDC | |
| Z-2152-2017 | Class II | Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for... | PAUSCH Medical GmbH | JAA | |
| Z-1065-2019 | Class II | Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1... | Accelerate Diagnostics, Inc. | PRH | |
| Z-0395-2018 | Class II | Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as... | Measurement Specialties, Inc. | FLL | |
| Z-0384-2018 | Class II | Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical... | Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International) | CAF | |
| Z-1831-2017 | Class II | NEODENT CM Intraoral Scanbody, Article Number: 108.139 | Straumann USA, LLC | NDP | |
| Z-1768-2017 | Class II | Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only... | Nihon Kohden America Inc | MHX | |
| Z-2071-2017 | Class II | Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the... | Stryker Corp. | PGW | |
| Z-1833-2017 | Class II | Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C | Siemens Healthcare Diagnostics Inc. | JMG | |
| Z-1780-2017 | Class II | Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD. | GE Healthcare | IYN | |
| Z-1832-2017 | Class I | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is... | HeartWare, Inc. | DSQ | |
| Z-1779-2017 | Class II | Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. | GE Healthcare | IYN |