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-0955-2020 | Class I | Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714... | Medtronic, Inc. | OZO | |
| Z-0719-2020 | Class II | 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3... | 3M Company | KGX | |
| Z-0706-2020 | Class II | DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP | DeRoyal Industries, Inc. | ITQ | |
| Z-3023-2020 | Class II | ProxiDiagnost N90 | Philips North America LLC | OWB | |
| Z-0941-2020 | Class II | Safeline Y-Type Blood Set, Catalog Number V2500 | B Braun Medical Inc | FPA | |
| Z-0940-2020 | Class II | Safeline Y-Type Blood Set, Catalog Number NF5140 | B Braun Medical Inc | FPA | |
| Z-0939-2020 | Class II | Y-Type Blood Set, Catalog Number 490530 | B Braun Medical Inc | FPA | |
| Z-0934-2020 | Class II | Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory... | Datascope Corp. | DSP | |
| Z-0933-2020 | Class II | Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory... | Datascope Corp. | DSP | |
| Z-0932-2020 | Class II | Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an... | Datascope Corp. | DSP | |
| Z-0938-2020 | Class II | Y-Type Blood Set, Catalog Number 490425 | B Braun Medical Inc | FPA | |
| Z-0937-2020 | Class II | Y-Type Blood Set, Catalog Number 490314 | B Braun Medical Inc | FPA | |
| Z-0936-2020 | Class II | Y-Type Blood Set, Catalog Number 490293 | B Braun Medical Inc | FPA | |
| Z-0935-2020 | Class II | Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005 | B Braun Medical Inc | FPA | |
| Z-1106-2020 | Class II | TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The... | Cardiac Assist, Inc | DWF | |
| Z-0954-2020 | Class I | LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for... | Respironics, Inc. | CBK | |
| Z-0953-2020 | Class I | Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for... | Respironics, Inc. | CBK | |
| Z-0952-2020 | Class I | Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended... | Respironics, Inc. | CBK | |
| Z-0951-2020 | Class I | Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended... | Respironics, Inc. | CBK | |
| Z-0950-2020 | Class I | Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is... | Respironics, Inc. | CBK | |
| Z-0949-2020 | Class I | Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for... | Respironics, Inc. | CBK | |
| Z-0948-2020 | Class I | Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for... | Respironics, Inc. | CBK | |
| Z-0947-2020 | Class I | Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended... | Respironics, Inc. | CBK | |
| Z-0946-2020 | Class I | Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for... | Respironics, Inc. | CBK | |
| Z-0945-2020 | Class I | Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for... | Respironics, Inc. | CBK | |
| Z-0944-2020 | Class I | Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for... | Respironics, Inc. | CBK | |
| Z-0943-2020 | Class I | Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for... | Respironics, Inc. | CBK | |
| Z-1104-2020 | Class II | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version... | Dexcom, Inc. | QBJ | |
| Z-1261-2020 | Class II | Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-1260-2020 | Class II | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-0942-2020 | Class I | Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended... | Respironics, Inc. | CBK | |
| Z-0713-2020 | Class II | MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated... | Boston Scientific Corporation | NZT | |
| Z-0712-2020 | Class II | MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are... | Boston Scientific Corporation | NZT | |
| Z-0711-2020 | Class II | MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors... | Boston Scientific Corporation | NZT | |
| Z-0710-2020 | Class II | OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage... | Boston Scientific Corporation | NZT | |
| Z-0709-2020 | Class II | OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F... | Boston Scientific Corporation | NZT | |
| Z-2642-2020 | Class III | LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case | LivaNova USA, Inc. | DTL | |
| Z-1803-2020 | Class II | ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian... | Viewray, Inc. | IYE | |
| Z-1962-2020 | Class II | Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The... | W. L. Gore & Associates, Inc. | DYB | |
| Z-0736-2020 | Class II | RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0836-2020 | Class II | Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020 | Paltop Advanced Dental Solutions Ltd | DZE | |
| Z-0738-2020 | Class II | STA SYSTEM CONROL N + P (ref. 00678) | Diagnostica Stago, Inc. | GGN | |
| Z-0737-2020 | Class II | STA UNICALIBRATOR (ref. 00675) | Diagnostica Stago, Inc. | GIZ | |
| Z-0668-2020 | Class II | Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The... | Boston Scientific Corporation | JOS | |
| Z-0667-2020 | Class II | Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The... | Boston Scientific Corporation | JOS | |
| Z-0772-2020 | Class II | There is a complaint regarding internal check cable guide mechanism failure for the... | Nucletron BV | JAQ | |
| Z-0673-2020 | Class II | BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in... | Leica Microsystems, Inc. | NJT | |
| Z-0687-2020 | Class II | Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC... | Southwest Technologies Inc | FRO | |
| Z-0767-2020 | Class II | O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 | Medtronic Navigation, Inc | OWB | |
| Z-0716-2020 | Class II | Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYG |