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-1034-2015 | Class II | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous... | Animas Corp. | OYC | |
| Z-0931-2012 | Duration packaging distributed by Stryker Orthopaedics, Limerick, Ireland Stryker... | Howmedica Osteonics Corp | MEH | ||
| Z-0361-2012 | Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers... | Philips North America LLC | JAK | ||
| Z-0360-2012 | Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial... | Philips North America LLC | JAK | ||
| Z-0141-2012 | Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health... | Medtronic, Inc. | LRP | ||
| Z-0140-2012 | Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal... | Medtronic, Inc. | LRO | ||
| Z-0088-2012 | O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL... | Go Medical Industries Pty., Ltd. | FCM | ||
| Z-0087-2012 | O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL... | Go Medical Industries Pty., Ltd. | FCM | ||
| Z-0086-2012 | O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL... | Go Medical Industries Pty., Ltd. | FCM | ||
| Z-0085-2012 | O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL... | Go Medical Industries Pty., Ltd. | FCM | ||
| Z-0084-2012 | O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL... | Go Medical Industries Pty., Ltd. | FCM | ||
| Z-0505-2012 | REF UT8150 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx... | Nurse Assist, LLC | KOD | ||
| Z-0504-2012 | REF UT8140 Urethal Insertion Tray Qty: 20 For Rx Only Sterile unless package is damaged... | Nurse Assist, LLC | KOD | ||
| Z-0503-2012 | REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx... | Nurse Assist, LLC | KOD | ||
| Z-0502-2012 | REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx... | Nurse Assist, LLC | KOD | ||
| Z-0501-2012 | WELCON TM BRAND REORDER NO. 8012 (STERILE) CATHETER CARE KIT 60 ea/Box nurse assist... | Nurse Assist, LLC | KOD | ||
| Z-0500-2012 | WELCON TM BRAND REORDER NO. 7402 (STERILE) URETHRAL CATHETER KIT (Female) 25 ea/Box nurse... | Nurse Assist, LLC | KOD | ||
| Z-0499-2012 | WELCON TM BRAND REORDER NO. 7401 (STERILE) URETHRAL CATHETER KIT With 3 Compartment... | Nurse Assist, LLC | KOD | ||
| Z-0498-2012 | WELCON TM BRAND REORDER NO. 7305 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml... | Nurse Assist, LLC | KOD | ||
| Z-0497-2012 | WELCON TM BRAND REORDER NO. 7304 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/30ml... | Nurse Assist, LLC | KOD | ||
| Z-0496-2012 | WELCON TM BRAND REORDER NO. 7303 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml... | Nurse Assist, LLC | KOD | ||
| Z-0495-2012 | WELCON TM BRAND REORDER NO. 7302 (STERILE) URETHRAL CATHETER TRAY w/ Red Rubber Catheter... | Nurse Assist, LLC | KOD | ||
| Z-0494-2012 | WELCON TM BRAND REORDER NO. 7301 (STERILE) URETHRAL CATHETER TRAY w/ Plastic Catheter 20... | Nurse Assist, LLC | KOD | ||
| Z-0493-2012 | WELCON TM BRAND REORDER NO. 7300 (STERILE) URETHRAL CATHETER TRAY w/o Plastic Catheter 20... | Nurse Assist, LLC | KOD | ||
| Z-0492-2012 | McKESSON Medi-Pak Foley Catheter Tray without Catheter For Use With 30 cc Foley Catheter... | Nurse Assist, LLC | KOD | ||
| Z-0491-2012 | McKESSON Medi-Pak Urethral Catheter Tray with Red Rubber Catheter Sterile.Single... | Nurse Assist, LLC | KOD | ||
| Z-0490-2012 | McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single... | Nurse Assist, LLC | KOD | ||
| Z-2664-2014 | Class II | The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to... | Philips North America LLC | JAK | |
| Z-1075-2012 | Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name... | Alere San Diego, Inc. | GTY | ||
| Z-1074-2012 | Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number)... | Alere San Diego, Inc. | GTY | ||
| Z-0595-2012 | Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is... | Therakos Inc | LNR | ||
| Z-0032-2012 | MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software... | Philips North America LLC | LLZ | ||
| Z-3279-2011 | The Trabecular Metal Modular Acetabular System is a modular acetabular cup system... | Zimmer GmbH | JDI | ||
| Z-0069-2012 | Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0038-2012 | Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-3173-2011 | BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally... | Bard Access Systems, Inc. | |||
| Z-0172-2012 | Shoulder Flex Massage Device Device is an electric personal massage device labeled in... | King International | ISA | ||
| Z-0149-2012 | Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec... | Medtronic, Inc. | OAE | ||
| Z-0779-2012 | Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial... | Philips North America LLC | JAK | ||
| Z-0778-2012 | Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial... | Philips North America LLC | JAK | ||
| Z-0777-2012 | Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243... | Philips North America LLC | JAK | ||
| Z-3214-2011 | Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO... | Terumo Cardiovascular Systems Corporation | DWB | ||
| Z-0107-2012 | GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. The MSK Extreme TM MR Scanner... | GE Healthcare | LNH | ||
| Z-0387-2012 | ActiveCare DVT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing... | Medical Compression Systems | JOW | ||
| Z-0386-2012 | ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing... | Medical Compression Systems | JOW | ||
| Z-0134-2012 | Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare... | Baxter Healthcare Corporation | FRN | ||
| Z-3278-2011 | Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the... | Abbott Medical | CJE | ||
| Z-0466-2012 | SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. SoftMic is a laboratory... | SCC Soft Computer | JQP | ||
| Z-3274-2011 | Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40"... | Stryker Corp. | KCY | ||
| Z-0029-2012 | OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine... | OLYMPUS Corporation of the Americas | FCG |