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-1360-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic... | Progressive Medical Inc | GEI | |
| Z-1359-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic... | Progressive Medical Inc | GEI | |
| Z-1341-2013 | Class II | Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050... | MEDLINE INDUSTRIES, LP - Northfield | OTO | |
| Z-1358-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic... | Progressive Medical Inc | GEI | |
| Z-1357-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic... | Progressive Medical Inc | GEI | |
| Z-1356-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY... | Progressive Medical Inc | GEI | |
| Z-1355-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic... | Progressive Medical Inc | GEI | |
| Z-1354-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY... | Progressive Medical Inc | GEI | |
| Z-1353-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic... | Progressive Medical Inc | GEI | |
| Z-1352-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic... | Progressive Medical Inc | GEI | |
| Z-1351-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY... | Progressive Medical Inc | GEI | |
| Z-1350-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic... | Progressive Medical Inc | GEI | |
| Z-1349-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY... | Progressive Medical Inc | GEI | |
| Z-1348-2013 | Class II | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY... | Progressive Medical Inc | GEI | |
| Z-1304-2013 | Class III | Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit. | Medtronic, Inc. | KDD | |
| Z-1303-2013 | Class III | Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV... | Medtronic, Inc. | LRS | |
| Z-0522-2014 | Class II | KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL | mobility unlimited Inc dba kayserbetten US | FNL | |
| Z-0613-2014 | Class II | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC... | Philips North America LLC | MKJ | |
| Z-1967-2013 | Class II | The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a... | GE Healthcare | KPS | |
| Z-1339-2013 | Class II | LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient... | Boston Scientific Corporation | LWS | |
| Z-1267-2013 | Class II | Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide... | Symmetry Surgical GmbH | DWS | |
| Z-2266-2013 | Class II | GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model... | GE Healthcare | LNH | |
| Z-1778-2013 | Class III | Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a... | National Biological Corp. | FTC | |
| Z-1784-2013 | Class II | HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for... | Instrumentation Laboratory Co. | GJS | |
| Z-0795-2014 | Class II | Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in... | Remel Inc | JTN | |
| Z-0794-2014 | Class II | Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in... | Remel Inc | JTN | |
| Z-0793-2014 | Class II | Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in... | Remel Inc | JTN | |
| Z-0792-2014 | Class II | Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in... | Remel Inc | JTN | |
| Z-1407-2013 | Class II | Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502... | Alpine Biomed ApS | GWF | |
| Z-2292-2013 | Class II | Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral... | Ebi, LLC | MAX | |
| Z-1772-2013 | Class II | Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks... | Ethicon Endo-Surgery Inc | GCJ | |
| Z-1779-2013 | Class III | Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a... | National Biological Corp. | FTC | |
| Z-1185-2013 | Class II | Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID... | Medtronic, Inc. | DRO | |
| Z-1184-2013 | Class II | Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID... | Medtronic, Inc. | DRO | |
| Z-1189-2013 | Class II | HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC... | Philips North America LLC | MKJ | |
| Z-1171-2013 | Class I | Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model... | Newport Medical Instruments, Inc. | CBK | |
| Z-1329-2013 | Class II | PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of... | MEDTOX Diagnostics, Inc. | DIO | |
| Z-0700-2016 | Class II | Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic... | Smith & Nephew, Inc. | NBH | |
| Z-0699-2016 | Class II | Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws... | Smith & Nephew, Inc. | HWR | |
| Z-0530-2014 | Class II | remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of... | Remel Inc | JXB | |
| Z-0425-2014 | Class II | 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers... | B Braun Medical Inc | LHI | |
| Z-0424-2014 | Class II | 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers... | B Braun Medical Inc | LHI | |
| Z-1403-2013 | Class II | PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage... | Polymer Technology Systems | NBW | |
| Z-1375-2013 | Class II | QuietCare. Intended for use in monitoring the environmental conditions and activity... | Intel-Ge Care Innovations, LLC | IQA | |
| Z-1374-2013 | Class II | QuietCare-Networked. Intended for use in monitoring the environmental conditions and... | Intel-Ge Care Innovations, LLC | IQA | |
| Z-1276-2013 | Class II | ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of... | Medshape, Inc. | MBI | |
| Z-1446-2013 | Class II | LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846... | Leica Microsystems, Inc. | IDZ | |
| Z-1182-2013 | Class II | Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1368-2013 | Class II | Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the... | Roche Diagnostics GmbH | JJE | |
| Z-2117-2013 | Class II | GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM... | GE Healthcare | MHX |
