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-1600-2010 | Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or... | Canon Medical Informatics, Inc. | LLZ | ||
| Z-1220-2010 | Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500... | STERIS Corporation | FTD | ||
| Z-1219-2010 | Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the... | STERIS Corporation | FTD | ||
| Z-1218-2010 | Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the... | STERIS Corporation | FTD | ||
| Z-2799-2011 | "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing... | ZimVie US Corp LLC | NSQ | ||
| Z-2391-2010 | Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser... | Abbott Medical | FRN | ||
| Z-2390-2010 | Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List... | Abbott Medical | FRN | ||
| Z-0128-2011 | Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser... | Abbott Medical | FRN | ||
| Z-0127-2011 | Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List... | Abbott Medical | FRN | ||
| Z-2115-2010 | TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming... | Accuray Incorporated | MUJ | ||
| Z-1435-2010 | Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL... | Orthofix SRL | JDW | ||
| Z-1434-2010 | Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600, manufactured by... | Orthofix SRL | JDW | ||
| Z-1425-2010 | Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude... | Abbott Medical | GZB | ||
| Z-1209-2010 | XiO Radiation Treatment Planning System, Release 4.51.00. | Elekta Limited | MUJ | ||
| Z-1255-2010 | Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551 | Encore Medical, LP | JWH | ||
| Z-1775-2010 | iBOT 4000 Mobility System Battery pack. | Independence Technology, LLC | IMK | ||
| Z-0628-2011 | ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a... | Advanced Sterilization Products | KOG | ||
| Z-1652-2010 | Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale... | Cepheid | OPU | ||
| Z-0316-2011 | BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San... | Becton, Dickinson and Company, BD Biosciences | GKZ | ||
| Z-1940-2010 | BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow... | Becton, Dickinson and Company, BD Biosciences | GKZ | ||
| Z-0159-2011 | Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by... | Elekta Limited | MUJ | ||
| Z-1651-2010 | Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale... | Cepheid | OPU | ||
| Z-1259-2011 | Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-1215-2010 | ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE... | Wright Medical Technology Inc | JWH | ||
| Z-1395-2010 | GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions... | GE Healthcare | LLZ | ||
| Z-1394-2010 | GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL... | GE Healthcare | LLZ | ||
| Z-1422-2010 | Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt... | Integra LifeSciences Corporation | GWM | ||
| Z-1174-2010 | UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long... | Urologix, LLC | MEQ | ||
| Z-1211-2010 | Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter, UPN M001125420... | Boston Scientific Corporation | LIT | ||
| Z-1210-2010 | Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040... | Boston Scientific Corporation | FGE | ||
| Z-1202-2010 | Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. The TOM... | Stryker Craniomaxillofacial Division | LXH | ||
| Z-2487-2010 | Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender... | Wally's Natural Products | |||
| Z-2621-2010 | Access Immunoassay Systems CORTISOL, Part Number: 33600 | Siemens Healthcare Diagnostics Inc. | CGR | ||
| Z-2620-2010 | Access Immunoassay Systems PROGESTERONE, Part Number: 33550 | Siemens Healthcare Diagnostics Inc. | JLS | ||
| Z-2402-2012 | Class II | A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical... | STERIS Corporation | FQO | |
| Z-0344-2011 | SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. SCC Soft Computer... | SCC Soft Computer | JQP | ||
| Z-0501-2011 | Zimmer Reconstruction System Offset Clamp Tips 4.5 cm Offset, Item # 00-1179-028-03... | Zimmer GmbH | HWN | ||
| Z-0500-2011 | Zimmer Reconstruction System Offset Clamp Tips 3.5 cm Offset, Item # 00-1179-028-02... | Zimmer GmbH | HWN | ||
| Z-0499-2011 | Zimmer Reconstruction System Offset Clamp Tips Inline, Item # 00-1179-028-01, Zimmer... | Zimmer GmbH | HWN | ||
| Z-0498-2011 | Zimmer Reconstruction System Tenaculum 3.5 mm Screw Tines, Item # 00-1179-026-00, Zimmer... | Zimmer GmbH | HWN | ||
| Z-0497-2011 | Zimmer Reconstruction System Tenaculum Standard 9 inch, Item # 00-1179-025-00, Zimmer... | Zimmer GmbH | HWN | ||
| Z-0496-2011 | Zimmer Reconstruction System Tenaculum 9 inch Length, One 3.5 mm Screw Tine, Item #... | Zimmer GmbH | HWN | ||
| Z-0495-2011 | Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item #... | Zimmer GmbH | HWN | ||
| Z-0494-2011 | Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch, Item #... | Zimmer GmbH | HWN | ||
| Z-0493-2011 | Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00... | Zimmer GmbH | HWN | ||
| Z-1423-2010 | Syngo Imaging XS model number 10496279 The intended use: image processing radiological | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-1312-2010 | Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-1530-2010 | Baxter Evacuated Container, 500 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare... | Baxter Healthcare Corporation | KPE | ||
| Z-1529-2010 | Baxter Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare... | Baxter Healthcare Corporation | KPE | ||
| Z-1528-2010 | Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx... | Baxter Healthcare Corporation | CGN |