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-2757-2011 | Blake Silicone Drain Kit Manufactured for: Ethicon, Inc. Somerville, New Jersey... | Ethicon, Inc | KOG | ||
| Z-2756-2011 | Blake Silicone Drain, 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey... | Ethicon, Inc | KOG | ||
| Z-2218-2011 | AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that... | Accriva Diagnostics, Inc. | DQA | ||
| Z-2719-2011 | PERPOS PLS SYSTEM, CATALOG NO. 9045-02 A sterile, medical device kit consisting of the... | Interventional Spine, Inc. | HXI | ||
| Z-2718-2011 | PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the... | Interventional Spine, Inc. | HXI | ||
| Z-2151-2011 | LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1... | Siemens Medical Solutions USA, Inc. | LMB | ||
| Z-3175-2011 | Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer... | Medtronic, Inc. | HRX | ||
| Z-1931-2011 | GE Healthcare, CARESCAPE Monitor B850 The CARESCAPE Monitor B650 is a multi-parameter... | GE Healthcare | MHX | ||
| Z-1930-2011 | GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter... | GE Healthcare | MHX | ||
| Z-1999-2011 | GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira... | Abbott Medical | FRN | ||
| Z-2551-2011 | Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | ||
| Z-2103-2011 | Confidence Introducer Needle Side Hole 13G x 4-Inch Product Code: 2839-04-413 The... | DePuy Spine, Inc. | OCJ | ||
| Z-2102-2011 | Confidence Diamond Tip Introducer Needle 11G x 6-Inch Product Code: 2839-03-611 The... | DePuy Spine, Inc. | OCJ | ||
| Z-0278-2012 | SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4... | SCC Soft Computer | LNX | ||
| Z-3120-2011 | Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12... | Lee Medical International Inc | FKG | ||
| Z-2123-2011 | Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot... | Allergan | LTI | ||
| Z-2111-2011 | Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory) Product Part... | Abbott Rapid Dx North America, LLC | KHE | ||
| Z-2110-2011 | Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part... | Abbott Rapid Dx North America, LLC | KHE | ||
| Z-2109-2011 | Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal... | Abbott Rapid Dx North America, LLC | KHE | ||
| Z-2108-2011 | Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test) Immunochemical Fecal... | Abbott Rapid Dx North America, LLC | KHE | ||
| Z-2107-2011 | Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette... | Abbott Rapid Dx North America, LLC | KHE | ||
| Z-2106-2011 | Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test... | Abbott Rapid Dx North America, LLC | KHE | ||
| Z-2552-2011 | IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular... | AGFA Healthcare Corp. | LLZ | ||
| Z-2701-2011 | CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product... | Cerenovus, Inc. | NJE | ||
| Z-1983-2011 | Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift... | Arjo, Inc. | FSA | ||
| Z-2176-2012 | Class II | Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a... | Howmedica Osteonics Corp | MDM | |
| Z-1192-2012 | Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and... | Visionsense, Ltd. | GWG | ||
| Z-2387-2011 | DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue... | Express Diagnostics Int'l., Inc. | DJG | ||
| Z-3204-2011 | Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a... | Varian Medical Systems, Inc. | IYE | ||
| Z-2191-2011 | Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad... | Eli Lilly and Company, Pharmaceutical Delivery Systems | KMJ | ||
| Z-0454-2012 | Dental cement under the brand name Cement-It and Natural Elegance (private label of... | Sybron Dental Specialties, Inc. | EMA | ||
| Z-3203-2011 | Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw... | The Anspach Effort, Inc. | HBC | ||
| Z-3202-2011 | Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw... | The Anspach Effort, Inc. | HBC | ||
| Z-2414-2011 | Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i... | Datascope Corp. | FMZ | ||
| Z-2129-2011 | APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO... | Baxter Healthcare Renal Div | FKX | ||
| Z-2175-2011 | Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue... | Philips North America LLC | NSX | ||
| Z-0362-2017 | Class II | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V... | Abbott Medical | FRN | |
| Z-0361-2017 | Class II | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V... | Abbott Medical | FRN | |
| Z-3046-2011 | Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By... | STERIS Corporation | JOJ | ||
| Z-3045-2011 | Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033... | STERIS Corporation | JOJ | ||
| Z-3034-2011 | Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated... | Interventional Spine, Inc. | MRW | ||
| Z-3033-2011 | PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 A sterile, medical device kit consisting of... | Interventional Spine, Inc. | MRW | ||
| Z-2558-2011 | OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes... | Opti Medical Systems Inc | CGZ | ||
| Z-2051-2011 | ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-2020-2011 | CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054 | Abbott Medical | GKZ | ||
| Z-2019-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. Abbott Diagnostics... | Abbott Medical | GKZ | ||
| Z-2018-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL... | Abbott Medical | GKZ | ||
| Z-2017-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS... | Abbott Medical | GKZ | ||
| Z-2016-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL... | Abbott Medical | GKZ | ||
| Z-2015-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL... | Abbott Medical | GKZ |