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-0664-2009 | Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number... | Globus Medical, Inc. | LWJ | ||
| Z-0337-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-460, UPN M001434601... | Boston Scientific Corporation | FCG | ||
| Z-0336-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-459, UPN M001434591... | Boston Scientific Corporation | FCG | ||
| Z-0335-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-458, UPN M001434581... | Boston Scientific Corporation | FCG | ||
| Z-0334-2009 | Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-457, UPN M001434571... | Boston Scientific Corporation | FCG | ||
| Z-0333-2009 | Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-456, UPN M001434561... | Boston Scientific Corporation | FCG | ||
| Z-0332-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-454, UPN M001434541... | Boston Scientific Corporation | FCG | ||
| Z-0331-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-453 , M001434531... | Boston Scientific Corporation | FCG | ||
| Z-0330-2009 | Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-451, UPN M001434511... | Boston Scientific Corporation | FCG | ||
| Z-0329-2009 | Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501... | Boston Scientific Corporation | FCG | ||
| Z-0328-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-452, UPN MOO1434521... | Boston Scientific Corporation | FCG | ||
| Z-0444-2009 | Medtronic Input TS 7F 11 cm Ref: 071102A Percutaneous catheter introducer sets... | Medtronic, Inc. | DYB | ||
| Z-0443-2009 | 7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 Percutaneous... | Medtronic, Inc. | DYB | ||
| Z-0442-2009 | 6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous... | Medtronic, Inc. | DYB | ||
| Z-0441-2009 | 5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11 Percutaneous... | Medtronic, Inc. | DYB | ||
| Z-0484-2009 | STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen... | Advanced Sterilization Products | MLR | ||
| Z-0319-2009 | AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global... | Datascope Corp. | BSZ | ||
| Z-0458-2009 | Gravity Compensating Accessory; High Pressure Range, Sterile, Single Use, Rx only. CSF... | Integra LifeSciences Corporation | JXG | ||
| Z-0202-2009 | Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software... | Draeger, Inc. | CBK | ||
| Z-0480-2009 | INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure... | Enterix, Inc. | KHE | ||
| Z-1186-2012 | ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983... | Siemens Healthcare Diagnostics Inc. | CEW | ||
| Z-0369-2010 | Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part... | Biosense Webster Inc | LPB | ||
| Z-0368-2010 | Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part... | Biosense Webster Inc | LPB | ||
| Z-0855-2009 | Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22... | Varian Medical Systems, Inc. | MUJ | ||
| Z-0652-2009 | Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006... | Stryker Corp. | HRX | ||
| Z-0582-2009 | QuantumPulse machine. Vibe Technologies, Greeley, CO. The device is used to create... | VIBE Technologies | |||
| Z-0201-2009 | Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer. | VIBE Technologies | |||
| Z-0280-2009 | 7F Bard SSV 13 cm Split Sheath with Valve and sideport Catalog Number: 808700 Distributed... | Boston Scientific Corporation | DYB | ||
| Z-0273-2009 | Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only... | Gyrus ACMI, Inc. | GEI | ||
| Z-0198-2009 | DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit) | DeRoyal Industries, Inc. | KDD | ||
| Z-0197-2009 | DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit) | DeRoyal Industries, Inc. | KDD | ||
| Z-1109-2010 | PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam... | Elekta Limited | MUJ | ||
| Z-0505-2009 | Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovative Implant Technology, The... | Innovative Implant Technology | NDP | ||
| Z-0581-2009 | Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2461-2010 | Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL... | Philips North America LLC | MOS | ||
| Z-0307-2009 | Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number... | Integra LifeSciences Corporation | HRS | ||
| Z-0328-2012 | GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled... | Varian Medical Systems, Inc. | JAQ | ||
| Z-0327-2012 | GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 200 mm. Remote controlled... | Varian Medical Systems, Inc. | JAQ | ||
| Z-0326-2012 | GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 mm. Remote controlled... | Varian Medical Systems, Inc. | JAQ | ||
| Z-0005-2009 | Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or... | Canon Medical Systems USA, Inc. | MQB | ||
| Z-0887-2009 | Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound... | Regenesis Biomedical Inc | ILX | ||
| Z-0609-2009 | DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is... | Medtronic Perfusion Systems | DWF | ||
| Z-0500-2009 | FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle... | Qualigen Inc | LTJ | ||
| Z-0485-2009 | Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in... | Siemens Healthcare Diagnostics Inc. | JFY | ||
| Z-0440-2009 | SteriLyte Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell... | Rockwell Medical | KPO | ||
| Z-0439-2009 | SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell... | Rockwell Medical | KPO | ||
| Z-0190-2009 | Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0189-2009 | Symbia T6 System; a dual-detector variable angle gamma camera with a six slice CT... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0596-2009 | Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS | Ossur Iceland ehf. | LYT | ||
| Z-0595-2009 | Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS | Ossur Iceland ehf. | LYT |