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-1125-2007 | Laser Distance and Level Transmitters, Model No. LM200, K-Tek, Prairieville, LA 70769 | K Tek | K--DD | ||
| Z-1124-2007 | Laser Distance and Level Transmitters, Model No. LT200, ASI, Housotn, TX 77024 | K Tek | K--DD | ||
| Z-1123-2007 | Laser Meter, Model No. LTM80, K-TEK, Prairieville, LA 70769 | K Tek | K--DD | ||
| Z-1122-2007 | LaserTrak, Model No. LT80, ASI, Houston, TX 77024 | K Tek | K--DD | ||
| Z-1121-2007 | Laser Level Transmitters, Model No. LM4C, K-TEK, 18321 Swamp Road, Prairieville, LA 70769 | K Tek | K--DD | ||
| Z-1120-2007 | Laser Distance and Level Transmitters, Model No. LT4C, ASI, 8570 Katy Freeway, Suite 117... | K Tek | K--DD | ||
| Z-0468-2007 | Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated... | Ossur Iceland ehf. | ISH | ||
| Z-0224-2007 | Roche Cobas driver (rchcob6i), analytical laboratory data interface. | Data Innovations, LLC | JQP | ||
| Z-0223-2007 | Roche Modular Drive (rchmdlri), analytical laboratory data interface. | Data Innovations, LLC | JQP | ||
| Z-0318-2007 | Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S | Edwards Lifesciences Technology SARL | FOZ | ||
| Z-0422-2007 | iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging... | Philips North America LLC | IYN | ||
| Z-0872-2007 | Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part)... | Smith & Nephew, Inc. | NBH | ||
| Z-0471-2007 | Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part... | Siemens Healthcare Diagnostics Inc. | JQP | ||
| Z-0208-2007 | Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is... | Medtronic, Inc. | ITX | ||
| Z-0265-2007 | OneTouch Basic/Profile Blood Glucose test strips. For use with One Touch Brand Meters... | Royal Global Wholesale | CGA | ||
| Z-0264-2007 | OneTouch Ultra- Blood Glucose test strips. For use with One Touch Brand Meters blood... | Royal Global Wholesale | NBW | ||
| Z-1485-06 | GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a... | GE Healthcare | JAA | ||
| Z-0267-2007 | AMO PhacoFlex Il Model SI40NB Intraocular Lenses | Advanced Medical Optics, Inc. | HQL | ||
| Z-0244-2007 | Rusch (Latex Free) Neoprene Pecan Shaped Breathing Bag with 15 mm neck insert, size 1... | Teleflex Medical | BYW | ||
| Z-0249-2007 | Sling Rope/Connector Assembly Kits for the Sara Power standing and raising aids; the kit... | Arjo, Inc. | FSA | ||
| Z-0248-2007 | Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids... | Arjo, Inc. | FSA | ||
| Z-0455-2008 | Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators... | Abbott Medical | GKZ | ||
| Z-0211-2007 | Portex Continuous Epidural tray Ref 4948-17 | Abbott Medical | CAZ | ||
| Z-0417-2007 | Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890 | Siemens Healthcare Diagnostics Inc. | DDC | ||
| Z-0447-2007 | REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265 | Respironics, Inc. | BTT | ||
| Z-0446-2007 | REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792... | Respironics, Inc. | BTT | ||
| Z-0479-2007 | BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600... | Arjo, Inc. | FSA | ||
| Z-0216-2007 | Propaq LT vital signs monitor, Model 802LTRN | Welch Allyn Protocol, Inc. | MWI | ||
| Z-0215-2007 | Propaq LT vital signs monitor, Model 802LTON | Welch Allyn Protocol, Inc. | MWI | ||
| Z-0481-2007 | Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654 | ZOLL Palm Springs | CBK | ||
| Z-0480-2007 | Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653 | ZOLL Palm Springs | CBK | ||
| Z-0176-2007 | Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111 | Medtronic Sofamor Danek USA Inc | LYS | ||
| Z-0414-2007 | AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available... | Stryker Sustainability Solutions | NLM | ||
| Z-0206-2007 | One Touch Ultra Blood Glucose test strips, LifeScan, a Johnson & Johnson Co., 50 test... | Discount Diabetic Supply | NBW | ||
| Z-0210-2007 | Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48... | Zimmer GmbH | HWT | ||
| Z-0357-2007 | Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok... | Continental Medical Labs,Inc | GCJ | ||
| Z-0227-2007 | CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional... | Roche Diagnostics GmbH | GJS | ||
| Z-1241-2007 | Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product... | Howmedica Osteonics Corp | JWH | ||
| Z-0317-2007 | FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0342-2007 | Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with... | LivaNova USA, Inc. | LYJ | ||
| Z-0341-2007 | Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1, v6.1.7... | LivaNova USA, Inc. | LYJ | ||
| Z-0207-2007 | OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test Strips per box. Part Number... | Medishop USA | NBW | ||
| Z-2393-2010 | Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC. Manufactured... | Invacare GmbH | FNL | ||
| Z-0922-2007 | EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly... | ZimVie US Corp LLC | DZE | ||
| Z-0494-2007 | Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0493-2007 | Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (Not... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0492-2007 | Terumo Advanced Perfusion System 1; Integrated (Sarns) Centrifugal System Control Unit... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0491-2007 | Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0490-2007 | Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0439-2007 | Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. | Terumo Cardiovascular Systems Corporation | DTQ |