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-2357-2016 | Class I | Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product... | Alere San Diego, Inc. | GJS | |
| Z-2356-2016 | Class I | Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT... | Alere San Diego, Inc. | GJS | |
| Z-2355-2016 | Class I | INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product... | Alere San Diego, Inc. | GJS | |
| Z-2354-2016 | Class I | Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere... | Alere San Diego, Inc. | GJS | |
| Z-2373-2016 | Class II | OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459... | Ivoclar Vivadent, Inc. | EHJ | |
| Z-0043-2017 | Class II | Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem... | Hill-Rom Inc. | JEA | |
| Z-0042-2017 | Class II | Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS... | Hill-Rom Inc. | JEA | |
| Z-0041-2017 | Class II | Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during... | Hill-Rom Inc. | JEA | |
| Z-0040-2017 | Class II | Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500... | Hill-Rom Inc. | JEA | |
| Z-2721-2016 | Class II | Medical Linear Accelerator | Elekta Limited | IYE | |
| Z-2342-2016 | Class I | NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents... | bioMerieux, Inc. | LDT | |
| Z-2578-2016 | Class II | Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2577-2016 | Class II | Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The... | Medtronic, Inc. | GEI | |
| Z-2576-2016 | Class II | Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2575-2016 | Class II | Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The... | Medtronic, Inc. | GEI | |
| Z-2574-2016 | Class II | Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The... | Medtronic, Inc. | GEI | |
| Z-2573-2016 | Class II | Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2572-2016 | Class II | Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The... | Medtronic, Inc. | GEI | |
| Z-2571-2016 | Class II | Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2570-2016 | Class II | Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code... | Medtronic, Inc. | GEI | |
| Z-2569-2016 | Class II | Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2568-2016 | Class II | Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2567-2016 | Class II | Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2566-2016 | Class II | Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2565-2016 | Class II | Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2564-2016 | Class II | Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2563-2016 | Class II | Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2562-2016 | Class II | Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2561-2016 | Class II | Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2560-2016 | Class II | Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 The... | Medtronic, Inc. | GEI | |
| Z-2559-2016 | Class II | Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 The Valleylab... | Medtronic, Inc. | GEI | |
| Z-2558-2016 | Class II | Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The... | Medtronic, Inc. | GEI | |
| Z-2557-2016 | Class II | Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code... | Medtronic, Inc. | GEI | |
| Z-2556-2016 | Class II | Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 The... | Medtronic, Inc. | GEI | |
| Z-2555-2016 | Class II | Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The... | Medtronic, Inc. | GEI | |
| Z-2554-2016 | Class II | Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The... | Medtronic, Inc. | GEI | |
| Z-2674-2016 | Class II | Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX... | Nakanishi Inc. | EFB | |
| Z-2673-2016 | Class II | Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG... | Nakanishi Inc. | ELC | |
| Z-2672-2016 | Class II | Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX... | Nakanishi Inc. | ELC | |
| Z-2217-2016 | Class II | Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog... | Eastman Kodak Company | IYN | |
| Z-1892-2017 | Class III | The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for... | Zimmer Trabecular Metal Technology, Inc. | MAX | |
| Z-2911-2016 | Class II | Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | |
| Z-0298-2017 | Class II | Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the... | TZ Medical Inc. | FRO | |
| Z-2795-2016 | Class II | T2CandidaCartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534... | T2 Biosystems Inc | PII | |
| Z-2670-2016 | Class II | UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10... | Philips North America LLC | OWB | |
| Z-2344-2016 | Class II | Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-2669-2016 | Class II | Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027... | Philips North America LLC | OWB | |
| Z-2547-2016 | Class II | Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The... | Bard Peripheral Vascular Inc | FCG | |
| Z-2297-2016 | Class II | SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R... | Smith & Nephew, Inc. | MEH | |
| Z-2330-2016 | Class II | EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in... | Agilent Technologies Denmark ApS | LDT |