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-2585-2011 | Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT... | Integra Lifesciences Sales LLC | LFL | ||
| Z-2411-2011 | Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed | Linet Americas | FNK | ||
| Z-2609-2011 | Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by... | Ela Medical, Inc. | MRM | ||
| Z-1993-2013 | Class II | Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated... | Artivion, Inc. | MNO | |
| Z-0827-2012 | Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457. | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-2394-2011 | URI-DRAIN Male Urinary Control Device - Large Product ID: 8884732598 (sold in Canada... | Medtronic, Inc. | KNX | ||
| Z-2393-2011 | URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin... | Medtronic, Inc. | KNX | ||
| Z-2392-2011 | URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective... | Medtronic, Inc. | KNX | ||
| Z-2420-2011 | Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only... | Haemonetics Corporation | CAC | ||
| Z-2240-2011 | Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. The... | Stryker Medical | IKY | ||
| Z-1430-2012 | Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute... | Ziehm Imaging GmbH | JAA | ||
| Z-3038-2011 | Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog... | Biosense Webster Inc | DRF | ||
| Z-3037-2011 | ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number... | Biosense Webster Inc | DRF | ||
| Z-2848-2011 | Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia... | Vital Signs, Inc. | BYD | ||
| Z-2660-2011 | Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET... | Zimmer GmbH | JDC | ||
| Z-2710-2011 | The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured... | Urologix, LLC | MEQ | ||
| Z-2216-2012 | Class III | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select | CliniSys, Inc | JQP | |
| Z-0914-2012 | enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic... | Ortho-Clinical Diagnostics, Inc. | JJE | ||
| Z-1129-2012 | DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an... | Carl Zeiss Microscopy, LLC | REK | ||
| Z-1128-2012 | Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging... | Carl Zeiss Microscopy, LLC | REK | ||
| Z-2891-2011 | DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer... | Deroyal Industries, Inc. Lafollette | LRP | ||
| Z-2787-2011 | Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital... | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-2610-2011 | CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-0446-2012 | Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh. | Osteopore International Pte Ltd | GXP | ||
| Z-2711-2011 | Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany... | Heinz Kurz GmbH Medizintechnik | ETA | ||
| Z-2600-2011 | Prism Laser 7642 Laser System | American Stress Technologies, Inc. | REO | ||
| Z-2704-2011 | Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ... | Vital Signs, Inc. | BYG | ||
| Z-2581-2011 | Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare... | GE Healthcare | DXQ | ||
| Z-2700-2011 | LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product... | Vygon U.S.A. | LJS | ||
| Z-2699-2011 | LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product... | Vygon U.S.A. | LJS | ||
| Z-2670-2011 | SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a... | Ameditech, Inc. | DKZ | ||
| Z-2239-2011 | Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0438-2013 | Class II | IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service... | Extremity Medical, LLC | HTO | |
| Z-0344-2012 | Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471... | Philips North America LLC | KPS | ||
| Z-0343-2012 | Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System... | Philips North America LLC | KPS | ||
| Z-2591-2011 | MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the... | miraDry, Inc. | OUB | ||
| Z-2550-2011 | Custom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF... | Zimmer GmbH | KWS | ||
| Z-2549-2011 | Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm... | Zimmer GmbH | KWS | ||
| Z-2548-2011 | Custom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics... | Zimmer GmbH | KWS | ||
| Z-2547-2011 | Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile... | Zimmer GmbH | KWS | ||
| Z-2546-2011 | Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548... | Zimmer GmbH | KWS | ||
| Z-2545-2011 | Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard... | Zimmer GmbH | KWS | ||
| Z-2544-2011 | Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile... | Zimmer GmbH | KWS | ||
| Z-2543-2011 | Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile... | Zimmer GmbH | KWS | ||
| Z-2542-2011 | Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single... | Zimmer GmbH | KWS | ||
| Z-2541-2011 | Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile... | Zimmer GmbH | KWS | ||
| Z-3029-2011 | BD Bactec Blood Culture Procedural Tray, Cat. Number 442805 Becton, Dickinson and... | Becton Dickinson & Co | JGE | ||
| Z-3028-2011 | BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 "... | Becton Dickinson & Co | KST | ||
| Z-2698-2011 | Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE... | Biomet U.K., Ltd. | HRY | ||
| Z-2929-2011 | remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name... | Remel Inc | JSO |