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-0702-03 | Tachos DR - Atrial TX Implantable Cardioverter Defibrillators | BIOTRONIK AG | LWS | ||
| Z-0701-03 | Deikos A+ Implantable Cardioverter Defibrillator | BIOTRONIK AG | LWS | ||
| Z-0700-03 | Tachos DR - Implantable Cardioverter Defibrillator. | BIOTRONIK AG | LWS | ||
| Z-0720-03 | CoaguChek PT test strips, sold in 12 pack. | Roche Diagnostics GmbH | JPA | ||
| Z-0706-03 | ICON DS hCG, an in-vitro diagnostic. Part number 44025. | Siemens Healthcare Diagnostics Inc. | JHI | ||
| Z-0927-03 | Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog #... | Abbott Medical | KOH | ||
| Z-0661-03 | Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FKP | ||
| Z-0660-03 | Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FKP | ||
| Z-0670-03 | Misys Laboratory System Version 5.3 | CliniSys, Inc | JQP | ||
| Z-0673-03 | CryoValve Allograft, heart valve | Artivion, Inc. | MIE | ||
| Z-0695-03 | Cidex Plus Solution Test Strips | Advanced Sterilization Products | 6885 | ||
| Z-0694-03 | Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips. | Advanced Sterilization Products | 6885 | ||
| Z-0658-03 | Flexgard, off-the-shelf knee brace, product number 14761106 | De Royal Industries | ITQ | ||
| Z-0622-03 | Custom Angiographic Kit | Merit Medical Systems, Inc. | DQO | ||
| Z-0621-03 | Custom Angiographic Kit | Merit Medical Systems, Inc. | DQO | ||
| Z-0620-03 | Custom Angiographic Kit. | Merit Medical Systems, Inc. | DQO | ||
| Z-0667-03 | COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system... | Roche Diagnostics GmbH | |||
| Z-0645-03 | Sterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc... | MEDLINE INDUSTRIES, LP - Northfield | MCY | ||
| Z-0714-03 | Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing... | GE Healthcare | BSF | ||
| Z-0713-03 | Multi Absorbers, reference number 8003138 | GE Healthcare | BSF | ||
| Z-0644-03 | Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL... | MEDLINE INDUSTRIES, LP - Northfield | GBX | ||
| Z-0716-03 | Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966. | Roche Diagnostics GmbH | LFR | ||
| Z-0715-03 | Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373... | Roche Diagnostics GmbH | LFR | ||
| Z-0730-03 | High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) Soda Lime USP-NF... | Darex Container Products Div of W.R. Grace & Co. | CBL | ||
| Z-0731-03 | Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl... | Darex Container Products Div of W.R. Grace & Co. | CBL | ||
| Z-1099-04 | LDL Cholesterol Reagent (LDLD) Part No. 969706 | Siemens Healthcare Diagnostics Inc. | MRR | ||
| Z-0907-03 | TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread. | Immedica, Inc. | LXT | ||
| Z-0623-03 | e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0617-03 | Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical... | Siemens Medical Solutions USA, Inc. | IYX | ||
| Z-0727-03 | ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission... | Siemens Medical Solutions USA, Inc. | JWM | ||
| Z-0574-03 | Invacare Lynx and Panther Scooters, motorized 3-wheeled vehicles. | Invacare GmbH | ITI | ||
| Z-0910-03 | Chauffeur Powered Scooters. | Electric Mobility | INI | ||
| Z-0657-03 | Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only). | Qiagen | MAQ | ||
| Z-0656-03 | Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296 | Qiagen | MAQ | ||
| Z-0655-03 | Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only. | Qiagen | MAQ | ||
| Z-0654-03 | Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096 | Qiagen | MAQ | ||
| Z-0688-03 | HeartMate Stroke Volume Limiter (SVL) Catalog # 1295 | Abbott Medical | DSQ | ||
| Z-0659-03 | TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016. | Interpore Cross International Inc | LXH | ||
| Z-0631-03 | Misys Laboratory System , Versions 5.2, 5.23 and 5.3 | CliniSys, Inc | JQP | ||
| Z-0616-03 | Chlamydia OIA. For in vitro diagnostic use. | Inverness Medical-Biostar, Inc. | LJC | ||
| Z-0615-03 | Chlamydia OIA. For in vitro diagnostic use, | Inverness Medical-Biostar, Inc. | LJC | ||
| Z-0909-03 | Rascal Powered Scooters. | Electric Mobility | INI | ||
| Z-0646-03 | Misys Laboratory System Version 5.3 | CliniSys, Inc | JQP | ||
| Z-1187-03 | Heart-valve, allograft | Artivion, Inc. | MIE | ||
| Z-0672-03 | CryoValve Allograft, Heart valve | Artivion, Inc. | MIE | ||
| Z-0629-03 | Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc... | bioMerieux, Inc. | GJS | ||
| Z-0707-03 | The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER... | Cordis US Corp. | FGE | ||
| Z-0633-03 | VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and... | Varian Medical Systems, Inc. | IYE | ||
| Z-0626-03 | Misys Laboratory System versions 5.2, 5.23 and 5.3 | CliniSys, Inc | JQP | ||
| Z-0614-03 | Misys Laboratory System Versions 5.2, 5.23 and 5.3 | CliniSys, Inc | JQP |