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-1532-2017 | Class II | ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX... | bioMerieux, Inc. | JWY | |
| Z-1531-2017 | Class II | ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM... | bioMerieux, Inc. | JWY | |
| Z-1530-2017 | Class II | ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM... | bioMerieux, Inc. | JWY | |
| Z-1529-2017 | Class II | ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a... | bioMerieux, Inc. | JWY | |
| Z-1528-2017 | Class II | ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM... | bioMerieux, Inc. | JWY | |
| Z-1527-2017 | Class II | ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG... | bioMerieux, Inc. | JWY | |
| Z-1526-2017 | Class II | ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST... | bioMerieux, Inc. | JWY | |
| Z-1525-2017 | Class II | ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA... | bioMerieux, Inc. | JWY | |
| Z-1524-2017 | Class II | Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST... | bioMerieux, Inc. | JWY | |
| Z-1523-2017 | Class II | ETEST Ceftriaxone TXL32 SPB, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a... | bioMerieux, Inc. | JWY | |
| Z-1522-2017 | Class II | ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE... | bioMerieux, Inc. | JWY | |
| Z-1521-2017 | Class II | ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ... | bioMerieux, Inc. | JWY | |
| Z-0940-2017 | Class II | TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries... | Nipro Vascular Innovations Americas, Inc. | OGZ | |
| Z-2107-2017 | Class II | 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline... | MEDLINE INDUSTRIES, LP - Northfield | LXH | |
| Z-2106-2017 | Class II | 14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline... | MEDLINE INDUSTRIES, LP - Northfield | LXH | |
| Z-2105-2017 | Class II | 10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline... | MEDLINE INDUSTRIES, LP - Northfield | LXH | |
| Z-2104-2017 | Class II | 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline... | MEDLINE INDUSTRIES, LP - Northfield | LXH | |
| Z-2103-2017 | Class II | 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline... | MEDLINE INDUSTRIES, LP - Northfield | LXH | |
| Z-1034-2017 | Class II | NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal... | Ultradent Products Inc. | EID | |
| Z-1111-2017 | Class II | SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems... | Organ Recovery Systems, Inc. | KDL | |
| Z-2684-2017 | Class II | Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus... | Ion Beam Applications S.A. | LHN | |
| Z-1416-2017 | Class III | Roth Net Polyp Retrieval | United States Endoscopy Group, Inc. | GCJ | |
| Z-1002-2017 | Class II | Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1001-2017 | Class II | Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1000-2017 | Class II | BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0999-2017 | Class II | Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0998-2017 | Class II | Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0997-2017 | Class II | Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0996-2017 | Class II | Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0995-2017 | Class II | Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0994-2017 | Class II | Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0993-2017 | Class II | Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0992-2017 | Class II | Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1781-2017 | Class II | Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package... | Boston Scientific Corporation | DQO | |
| Z-1057-2017 | Class II | Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal... | On-X Life Technologies Inc. | PAW | |
| Z-1112-2017 | Class II | SwishTapered Implant | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-1075-2017 | Class II | Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are... | PENTAX of America, Inc. | EQL | |
| Z-1051-2017 | Class II | Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture... | Great Basin Scientific, Inc. | PAM | |
| Z-1007-2017 | Class II | AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed... | Medtronic Navigation, Inc | HAW | |
| Z-1252-2017 | Class II | Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R... | OLYMPUS Corporation of the Americas | NWB | |
| Z-1251-2017 | Class II | URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope | OLYMPUS Corporation of the Americas | FBN | |
| Z-0984-2017 | Class II | Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59... | MEDLINE INDUSTRIES, LP - Northfield | KMJ | |
| Z-2759-2017 | Class II | Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using... | Abbott Medical | FPA | |
| Z-0267-2018 | Class II | I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in... | C.R. Bard Inc | KXK | |
| Z-1062-2017 | Class II | Velara Generator with an old Firmware version used with the Philips Integris BH5000 | Philips North America LLC | IZI | |
| Z-1061-2017 | Class II | Velara Generator with an old Firmware version used with Philips Allura Xper Systems... | Philips North America LLC | IZI | |
| Z-0962-2017 | Class II | Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D... | Medtronic, Inc. | NIK | |
| Z-0982-2017 | Class II | StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit... | Bard Access Systems, Inc. | KMK | |
| Z-0981-2017 | Class II | StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single... | Bard Access Systems, Inc. | KMK | |
| Z-1017-2017 | Class II | Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and... | Merge Healthcare Incorporated | HKI |